+ All documents
Home > Documents > Single incision versus conventional multi-incision appendicectomy for suspected appendicitis

Single incision versus conventional multi-incision appendicectomy for suspected appendicitis

Date post: 01-Dec-2023
Category:
Upload: rgu
View: 0 times
Download: 0 times
Share this document with a friend
23
Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review) Rehman H, Rao AM, Ahmed I This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 7 http://www.thecochranelibrary.com Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Transcript

Single incision versus conventional multi-incision

appendicectomy for suspected appendicitis (Review)

Rehman H Rao AM Ahmed I

This is a reprint of a Cochrane review prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2011 Issue 7

httpwwwthecochranelibrarycom

Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

T A B L E O F C O N T E N T S

1HEADER 1ABSTRACT 2PLAIN LANGUAGE SUMMARY 2BACKGROUND 3OBJECTIVES 3METHODS 6RESULTS 6DISCUSSION 7AUTHORSrsquo CONCLUSIONS 7ACKNOWLEDGEMENTS 7REFERENCES

10CHARACTERISTICS OF STUDIES 20DATA AND ANALYSES 20APPENDICES 20HISTORY 20CONTRIBUTIONS OF AUTHORS 21DECLARATIONS OF INTEREST 21DIFFERENCES BETWEEN PROTOCOL AND REVIEW 21INDEX TERMS

iSingle incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

[Intervention Review]

Single incision versus conventional multi-incisionappendicectomy for suspected appendicitis

Haroon Rehman1 Ahsan M Rao2 Irfan Ahmed3

1General Surgery University of Aberdeen Aberdeen UK 2Department of Surgery Aberdeen Royal Infirmary NHS GrampianAberdeen UK 3Department of Surgery Aberdeen Royal Infirmary Aberdeen UK

Contact address Haroon Rehman General Surgery University of Aberdeen Aberdeen Royal Infirmary Foresterhill Aberdeen ScotlandAB25 2ZD UK haroonrehman06aberdeenacuk

Editorial group Cochrane Colorectal Cancer GroupPublication status and date New published in Issue 7 2011Review content assessed as up-to-date 31 January 2011

Citation Rehman H Rao AM Ahmed I Single incision versus conventional multi-incision appendicectomy for suspected appendicitisCochrane Database of Systematic Reviews 2011 Issue 7 Art No CD009022 DOI 10100214651858CD009022pub2

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

A B S T R A C T

Background

Appendicectomy is a well established surgical procedure used in the management of acute appendicitis The operation can be performedwith minimally invasive surgery (laparoscopic) or as an open procedure A recent development in appendicectomy has been theintroduction of less invasive single incision laparoscopic surgery using a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision There are yet unanswered questions regarding the efficacy of this new and novel technique includingpatient benefit and satisfaction complications long-term outcomes and survival

Objectives

The aim of this review is to perform meta-analysis using data from available trials comparing single incision with conventional multi-incision laparoscopic appendicectomy for appendicitis in order to ascertain any differences in outcome

Search strategy

We searched the electronic databases including MEDLINEPubMed (from 1980 to December 2010) EMBASEOvid (from 1980 toDecember 2010) and CENTRAL (The Cochrane Library 2010 Issue 11) with pre-specified terms We also searched reference lists ofrelevant articles and reviews conference proceedings and ongoing trial databases

Selection criteria

Randomised or quasi-randomised controlled trials of patients with appendicitis or symptoms of appendicitis undergoing laparoscopicappendicectomy in which at least one arm involves single incision procedures and another multi-incision procedures

Data collection and analysis

There were no RCTs or prospectively controlled trials found that met the inclusion criteria

Main results

Three authors performed study selection independently

No studies that met the inclusion criteria of this review were identified Current evidence exists only the form of case-series

This review has been authored as rsquoemptyrsquo pending the results of 5 ongoing trials

1Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Authorsrsquo conclusions

No RCTs comparing single incision laparoscopic appendectomy with multi-incision surgery could be identified No definitive conclu-sions can be made at this time Well designed prospective RCTs are required in order to evaluate benefit or harm from laparoscopicsurgical approaches for appendicectomy Until appropriate data has been reported the institutional polices of healthcare providers mustbe based on the clinical judgement of experts in the field

P L A I N L A N G U A G E S U M M A R Y

Currently there is no evidence available from randomised control trials to determine whether Single Incision Laparoscopic

Surgery provides any better effect than Conventional Multi-incision Laparoscopic Surgery for appendicectomy

Laparoscopic appendicectomy is used in treating appendicitis and can be achieved using several skin incisions in the abdominal wallor more recently with a single skin incision through which instruments are introduced into the peritoneal cavity Since no randomisedcontrol trials of single incision versus conventional multi-incision laparoscopic surgery for appendicectomy could be found the efficacyand safety of the two approaches could not be analysed in this review There is a need for randomised control trials of single incisionlaparoscopic appendicectomy for appendicitis

B A C K G R O U N D

Appendicectomy refers to the surgical removal of the appendixappendicectomy is frequently performed as an emergency proce-dure in the management of a patient suffering from acute appen-dicitis a condition in which the appendix becomes inflamed Theoperation can be performed with minimally invasive surgery (la-paroscopic) or as an open procedure

A recent development in appendicectomy has been the intro-duction of less invasive Single Incision Laparoscopic Surgery us-ing a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision

Description of the condition

Appendicitis presents a lifetime risk of 7-8 and is recognizedglobally as the most common cause of acute abdominal pain (Addiss 1990)The aetiology of acute appendicitis remains poorly understoodbut is likely to be caused by luminal obstruction (Addiss 1990)Causative agents include fecalith hyperplastic lymphoid tissueforeign bodies parasitic infection and luminal obstruction due toprimary and secondary tumor Common microbial flora impli-cated in acute appendicitis include Ecoli Klebsiella Proteus andBacteriodes group (Bennion 1990 Blewett 1995 Rautio 2000)Following obstruction of the lumen continued mucus secretionsubsequently results in increased intraluminal pressure and lumi-nal distension This may culminate in thrombosis and occlusionof small blood vessels and lymph flow stasis resulting in tissue

ischaemia A damaged mucosal barrier allows bacterial invasionof the luminal wall causing transluminal inflammation (Birnbaum2000) Continued ischemia can result in appendiceal infarctionand perforation (Mason 2008)In 1886 Fitz described the signs symptoms and progression ofacute through to perforated appendicitis recommending early ap-pendicectomy for spreading peritonitis and clinical deteriorationIn 1894 McBurney defined the surgical appendicectomy and ithas since been used to significantly lower the mortality rate of thedisease (Birnbaum 2000)

Description of the intervention

Since its introduction appendicectomy has been the primary treat-ment of choice for acute appendicitis and although antibiotics dohave some established use surgery remains the treatment of choice(Hansson 2009) Today approximately 8 of the population inthe developed world can expect to undergo appendicectomy foracute appendicitis over their lifetime (Addiss 1990)The open appendicectomy procedure remained practically un-changed for over a century evolving only with the introductionof minimally invasive surgical techniques first described in 1983(Semm 1983) Possible advantages of laparoscopic techniques in-clude quicker and less painful recovery less postoperative com-plications and better cosmetic results Diagnostic tools such asultrasonography (US) and computed tomography (CT) are usedto reduce the number of negative findings at surgery (van Randen2008)

2Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Since its introduction laparoscopic appendicectomy has under-gone a number of modifications In 1998 Scheir reduced thenumber of ports used for the procedure to two (one for graspingforceps and one for scope) (Schier 1998) Today single incisionlaparoscopic surgery first proposed by Pelosi 1992 is technicallyfeasible It further minimizes the trauma of surgery and is increas-ingly being considered a safe alternative to conventional methods(Hong 2009 Meyer 2004 Rispoli 2002)Although the mortality rate as a result of appendicectomy is lessthan 05 overall complication rates are 111 and 87 forthe open and laparoscopic procedures respectively (Guller 2004)Complications include wound infection abscess formation andileus consequently resulting morbidity and increased length ofhospital stay The minimally invasive technique is reported to havea slightly higher intraabdominal abscess rate but a significantlylower wound infection rate (Sauerland 2004)

How the intervention might work

Minimally invasive surgery (laparoscopic) offers many benefitsover open surgery with a direct impact on patient recovery (Keus2006) The insult to the body (ie abdominal wall trauma) fromminimally invasive procedures is less severe than traditional opensurgery which means potential for reduced pain quicker healinglower wound complications better cosmetic results and shorterhospital stay (Sauerland 2004) Further reducing the abdominalwall trauma is the aim of single incision surgery hence furtherreducing wound complication rates and pain scores (Ates 2007)It has been reported in studies that postoperative pain is reducedwith smaller and fewer trocars (Bisgaard 2000 Bisgaard 2002Palanivelu 2008)This review will concentrate on single incision laparoscopic ap-pendicectomy comparing it with conventional minimally invasive(laparoscopic) surgery

Why it is important to do this review

The increasing variety of treatment options for appendicitis in-dicates a lack of consensus There are yet unanswered questionsregarding the efficacy of new and novel techniques including pa-tient benefit and satisfaction complications long-term outcomesand survivalProvided a sufficient number of trials of adequate quality havebeen conducted the best evidence will come from an easily acces-sible periodically updated comprehensive systematic review Itwill incorporate all available data identify best practice and alsohighlight gaps in the evidence baseWe aim to assess the outcomes for single incision versus multi-incision laparoscopic appendicectomy for appendicitis

O B J E C T I V E S

The aim of this review is to perform meta-analysis using data fromavailable trials comparing single incision laparoscopic appendicec-tomy with conventional multi-incision appendectomy for appen-dicitis

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised or quasi-randomised controlled trials of patients withappendicitis or symptoms of appendicitis undergoing laparo-scopic appendectomy in which at least one arm involves singleincision procedures and another multi-incision

Types of participants

All patients undergoing single incision or multi-incision laparo-scopic appendectomy for appendicitis diagnosed either clinicallyor with imaging will be included Studies evaluating single in-cision laparoscopic appendicectomy in children will be analysedseparately

Types of interventions

At least one arm had to include a single-incision laparoscopic ap-pendectomy procedure to treat acute or interval appendicitis re-gardless of pathology results Conventional multi-incision laparo-scopic appendectomy was the intervention with which compari-son was madeSpecific comparisons included(1) Transumbilical single incision versus conventional multi-inci-sion laparoscopic appendicectomy in adults A single trans-um-bilical skin incision is made allowing a specialised commerciallyavailable single port device to be placed through the fascia orconventional ports to be place through multiple closely-spaced in-cisions(2) Transumbilical single incision with use of specialised singleport device versus conventional multi-incision laparoscopic ap-pendicectomy in children Intervention as for (1)

Types of outcome measures

Primary outcomes

Clinical outcomes

3Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

10 Complications (rate)11 Intraoperative (rate)111 Estimated blood loss (volume ml)112 Serosal Injury to the bowel (rate)113 Intestinal perforation (rate)114 Injury to solid organs (rate)12 Early post-op (rate)121 Wound infection (rate)122 Ileus (rate)123 Intra-abdmoninal collections (rate)13 Late post-op (rate)131 Incisional herniation (rate)14 Conversion to laparoscopic (use of more than 1 additionalport site) open surgery (rate)15 Use of additional port site (rate)16 Operating time (minutes)17 30-day mortality (rate)18 Histological confirmation of appendicitis (rate)19 Negative appendicectomyPatient reported

1 Pain score postoperative (cm VAS)2 Qol3 Cosmesis

Secondary outcomes

1 Analgesia requirements (mgday)2 Incision length (cm)3 Length of hospital stay (days)4 Return to normal activities (days)5 Cost analysis

Search methods for identification of studies

Electronic searches

We searched the following electronic databases December 2010bull Cochrane Central Register of Controlled Clinical Trials

(CENTRAL)bull MEDLINE (OvidSP)bull EMBASE (OvidSP)bull WHO international trial register

The search was limited to publications after 1983 because this iswhen laparoscopic procedures were first introduced There wasno limitation based on language Please see Appendix 1 for searchstrategy

Searching other resources

The authors inspected references of all identified studies for moretrials of interest All potential studies for the review were cross ref-erenced Published abstracts from relevant conference proceedingswere hand searchedThe authors of this review contacted the first author of each in-cluded study for more information on duplicate publications oron unpublished trials

Data collection and analysis

Since no eligible studies were identified data collection and analysishave not been performed

Selection of studies

Two independent authors HR and IA reviewed the selected stud-ies independently In cases of disagreement about inclusion or ex-clusion of the study a third author AR reviewed the study and aconsensus was reached

Data extraction and management

If eligible studies had been identified data extraction would havebeen undertaken independently by two reviewers using a standardform containing pre-specified outcomes Clarification would besought where there has been potential data collection but notreportingAny differences of opinion would have been resolved among re-viewers and where necessary referred to a fourth party for arbitra-tionThis review was conducted using standard Cochrane softwarelsquoRevman 5rsquo When data becomes available included trial data willbe processed as described in the Cochrane Reviewersrsquo handbook(Higgins 2008)

Assessment of risk of bias in included studies

If eligible studies had been identified assessment of methodolog-ical quality would have been undertaken independently by eachreviewer using the criteria described in the Cochrane Collabo-ration Handbook (Higgins 2008) Dissagreements would be re-solved through discussion The system for classifying methodolog-ical quality of controlled trials is based on the following sources ofbiasSequence generation

bull Low risk of bias (the methods used was either adequate(eg computer generated random numbers table of randomnumbers) or unlikely to introduce confounding)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to introduceconfounding)

4Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

T A B L E O F C O N T E N T S

1HEADER 1ABSTRACT 2PLAIN LANGUAGE SUMMARY 2BACKGROUND 3OBJECTIVES 3METHODS 6RESULTS 6DISCUSSION 7AUTHORSrsquo CONCLUSIONS 7ACKNOWLEDGEMENTS 7REFERENCES

10CHARACTERISTICS OF STUDIES 20DATA AND ANALYSES 20APPENDICES 20HISTORY 20CONTRIBUTIONS OF AUTHORS 21DECLARATIONS OF INTEREST 21DIFFERENCES BETWEEN PROTOCOL AND REVIEW 21INDEX TERMS

iSingle incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

[Intervention Review]

Single incision versus conventional multi-incisionappendicectomy for suspected appendicitis

Haroon Rehman1 Ahsan M Rao2 Irfan Ahmed3

1General Surgery University of Aberdeen Aberdeen UK 2Department of Surgery Aberdeen Royal Infirmary NHS GrampianAberdeen UK 3Department of Surgery Aberdeen Royal Infirmary Aberdeen UK

Contact address Haroon Rehman General Surgery University of Aberdeen Aberdeen Royal Infirmary Foresterhill Aberdeen ScotlandAB25 2ZD UK haroonrehman06aberdeenacuk

Editorial group Cochrane Colorectal Cancer GroupPublication status and date New published in Issue 7 2011Review content assessed as up-to-date 31 January 2011

Citation Rehman H Rao AM Ahmed I Single incision versus conventional multi-incision appendicectomy for suspected appendicitisCochrane Database of Systematic Reviews 2011 Issue 7 Art No CD009022 DOI 10100214651858CD009022pub2

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

A B S T R A C T

Background

Appendicectomy is a well established surgical procedure used in the management of acute appendicitis The operation can be performedwith minimally invasive surgery (laparoscopic) or as an open procedure A recent development in appendicectomy has been theintroduction of less invasive single incision laparoscopic surgery using a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision There are yet unanswered questions regarding the efficacy of this new and novel technique includingpatient benefit and satisfaction complications long-term outcomes and survival

Objectives

The aim of this review is to perform meta-analysis using data from available trials comparing single incision with conventional multi-incision laparoscopic appendicectomy for appendicitis in order to ascertain any differences in outcome

Search strategy

We searched the electronic databases including MEDLINEPubMed (from 1980 to December 2010) EMBASEOvid (from 1980 toDecember 2010) and CENTRAL (The Cochrane Library 2010 Issue 11) with pre-specified terms We also searched reference lists ofrelevant articles and reviews conference proceedings and ongoing trial databases

Selection criteria

Randomised or quasi-randomised controlled trials of patients with appendicitis or symptoms of appendicitis undergoing laparoscopicappendicectomy in which at least one arm involves single incision procedures and another multi-incision procedures

Data collection and analysis

There were no RCTs or prospectively controlled trials found that met the inclusion criteria

Main results

Three authors performed study selection independently

No studies that met the inclusion criteria of this review were identified Current evidence exists only the form of case-series

This review has been authored as rsquoemptyrsquo pending the results of 5 ongoing trials

1Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Authorsrsquo conclusions

No RCTs comparing single incision laparoscopic appendectomy with multi-incision surgery could be identified No definitive conclu-sions can be made at this time Well designed prospective RCTs are required in order to evaluate benefit or harm from laparoscopicsurgical approaches for appendicectomy Until appropriate data has been reported the institutional polices of healthcare providers mustbe based on the clinical judgement of experts in the field

P L A I N L A N G U A G E S U M M A R Y

Currently there is no evidence available from randomised control trials to determine whether Single Incision Laparoscopic

Surgery provides any better effect than Conventional Multi-incision Laparoscopic Surgery for appendicectomy

Laparoscopic appendicectomy is used in treating appendicitis and can be achieved using several skin incisions in the abdominal wallor more recently with a single skin incision through which instruments are introduced into the peritoneal cavity Since no randomisedcontrol trials of single incision versus conventional multi-incision laparoscopic surgery for appendicectomy could be found the efficacyand safety of the two approaches could not be analysed in this review There is a need for randomised control trials of single incisionlaparoscopic appendicectomy for appendicitis

B A C K G R O U N D

Appendicectomy refers to the surgical removal of the appendixappendicectomy is frequently performed as an emergency proce-dure in the management of a patient suffering from acute appen-dicitis a condition in which the appendix becomes inflamed Theoperation can be performed with minimally invasive surgery (la-paroscopic) or as an open procedure

A recent development in appendicectomy has been the intro-duction of less invasive Single Incision Laparoscopic Surgery us-ing a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision

Description of the condition

Appendicitis presents a lifetime risk of 7-8 and is recognizedglobally as the most common cause of acute abdominal pain (Addiss 1990)The aetiology of acute appendicitis remains poorly understoodbut is likely to be caused by luminal obstruction (Addiss 1990)Causative agents include fecalith hyperplastic lymphoid tissueforeign bodies parasitic infection and luminal obstruction due toprimary and secondary tumor Common microbial flora impli-cated in acute appendicitis include Ecoli Klebsiella Proteus andBacteriodes group (Bennion 1990 Blewett 1995 Rautio 2000)Following obstruction of the lumen continued mucus secretionsubsequently results in increased intraluminal pressure and lumi-nal distension This may culminate in thrombosis and occlusionof small blood vessels and lymph flow stasis resulting in tissue

ischaemia A damaged mucosal barrier allows bacterial invasionof the luminal wall causing transluminal inflammation (Birnbaum2000) Continued ischemia can result in appendiceal infarctionand perforation (Mason 2008)In 1886 Fitz described the signs symptoms and progression ofacute through to perforated appendicitis recommending early ap-pendicectomy for spreading peritonitis and clinical deteriorationIn 1894 McBurney defined the surgical appendicectomy and ithas since been used to significantly lower the mortality rate of thedisease (Birnbaum 2000)

Description of the intervention

Since its introduction appendicectomy has been the primary treat-ment of choice for acute appendicitis and although antibiotics dohave some established use surgery remains the treatment of choice(Hansson 2009) Today approximately 8 of the population inthe developed world can expect to undergo appendicectomy foracute appendicitis over their lifetime (Addiss 1990)The open appendicectomy procedure remained practically un-changed for over a century evolving only with the introductionof minimally invasive surgical techniques first described in 1983(Semm 1983) Possible advantages of laparoscopic techniques in-clude quicker and less painful recovery less postoperative com-plications and better cosmetic results Diagnostic tools such asultrasonography (US) and computed tomography (CT) are usedto reduce the number of negative findings at surgery (van Randen2008)

2Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Since its introduction laparoscopic appendicectomy has under-gone a number of modifications In 1998 Scheir reduced thenumber of ports used for the procedure to two (one for graspingforceps and one for scope) (Schier 1998) Today single incisionlaparoscopic surgery first proposed by Pelosi 1992 is technicallyfeasible It further minimizes the trauma of surgery and is increas-ingly being considered a safe alternative to conventional methods(Hong 2009 Meyer 2004 Rispoli 2002)Although the mortality rate as a result of appendicectomy is lessthan 05 overall complication rates are 111 and 87 forthe open and laparoscopic procedures respectively (Guller 2004)Complications include wound infection abscess formation andileus consequently resulting morbidity and increased length ofhospital stay The minimally invasive technique is reported to havea slightly higher intraabdominal abscess rate but a significantlylower wound infection rate (Sauerland 2004)

How the intervention might work

Minimally invasive surgery (laparoscopic) offers many benefitsover open surgery with a direct impact on patient recovery (Keus2006) The insult to the body (ie abdominal wall trauma) fromminimally invasive procedures is less severe than traditional opensurgery which means potential for reduced pain quicker healinglower wound complications better cosmetic results and shorterhospital stay (Sauerland 2004) Further reducing the abdominalwall trauma is the aim of single incision surgery hence furtherreducing wound complication rates and pain scores (Ates 2007)It has been reported in studies that postoperative pain is reducedwith smaller and fewer trocars (Bisgaard 2000 Bisgaard 2002Palanivelu 2008)This review will concentrate on single incision laparoscopic ap-pendicectomy comparing it with conventional minimally invasive(laparoscopic) surgery

Why it is important to do this review

The increasing variety of treatment options for appendicitis in-dicates a lack of consensus There are yet unanswered questionsregarding the efficacy of new and novel techniques including pa-tient benefit and satisfaction complications long-term outcomesand survivalProvided a sufficient number of trials of adequate quality havebeen conducted the best evidence will come from an easily acces-sible periodically updated comprehensive systematic review Itwill incorporate all available data identify best practice and alsohighlight gaps in the evidence baseWe aim to assess the outcomes for single incision versus multi-incision laparoscopic appendicectomy for appendicitis

O B J E C T I V E S

The aim of this review is to perform meta-analysis using data fromavailable trials comparing single incision laparoscopic appendicec-tomy with conventional multi-incision appendectomy for appen-dicitis

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised or quasi-randomised controlled trials of patients withappendicitis or symptoms of appendicitis undergoing laparo-scopic appendectomy in which at least one arm involves singleincision procedures and another multi-incision

Types of participants

All patients undergoing single incision or multi-incision laparo-scopic appendectomy for appendicitis diagnosed either clinicallyor with imaging will be included Studies evaluating single in-cision laparoscopic appendicectomy in children will be analysedseparately

Types of interventions

At least one arm had to include a single-incision laparoscopic ap-pendectomy procedure to treat acute or interval appendicitis re-gardless of pathology results Conventional multi-incision laparo-scopic appendectomy was the intervention with which compari-son was madeSpecific comparisons included(1) Transumbilical single incision versus conventional multi-inci-sion laparoscopic appendicectomy in adults A single trans-um-bilical skin incision is made allowing a specialised commerciallyavailable single port device to be placed through the fascia orconventional ports to be place through multiple closely-spaced in-cisions(2) Transumbilical single incision with use of specialised singleport device versus conventional multi-incision laparoscopic ap-pendicectomy in children Intervention as for (1)

Types of outcome measures

Primary outcomes

Clinical outcomes

3Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

10 Complications (rate)11 Intraoperative (rate)111 Estimated blood loss (volume ml)112 Serosal Injury to the bowel (rate)113 Intestinal perforation (rate)114 Injury to solid organs (rate)12 Early post-op (rate)121 Wound infection (rate)122 Ileus (rate)123 Intra-abdmoninal collections (rate)13 Late post-op (rate)131 Incisional herniation (rate)14 Conversion to laparoscopic (use of more than 1 additionalport site) open surgery (rate)15 Use of additional port site (rate)16 Operating time (minutes)17 30-day mortality (rate)18 Histological confirmation of appendicitis (rate)19 Negative appendicectomyPatient reported

1 Pain score postoperative (cm VAS)2 Qol3 Cosmesis

Secondary outcomes

1 Analgesia requirements (mgday)2 Incision length (cm)3 Length of hospital stay (days)4 Return to normal activities (days)5 Cost analysis

Search methods for identification of studies

Electronic searches

We searched the following electronic databases December 2010bull Cochrane Central Register of Controlled Clinical Trials

(CENTRAL)bull MEDLINE (OvidSP)bull EMBASE (OvidSP)bull WHO international trial register

The search was limited to publications after 1983 because this iswhen laparoscopic procedures were first introduced There wasno limitation based on language Please see Appendix 1 for searchstrategy

Searching other resources

The authors inspected references of all identified studies for moretrials of interest All potential studies for the review were cross ref-erenced Published abstracts from relevant conference proceedingswere hand searchedThe authors of this review contacted the first author of each in-cluded study for more information on duplicate publications oron unpublished trials

Data collection and analysis

Since no eligible studies were identified data collection and analysishave not been performed

Selection of studies

Two independent authors HR and IA reviewed the selected stud-ies independently In cases of disagreement about inclusion or ex-clusion of the study a third author AR reviewed the study and aconsensus was reached

Data extraction and management

If eligible studies had been identified data extraction would havebeen undertaken independently by two reviewers using a standardform containing pre-specified outcomes Clarification would besought where there has been potential data collection but notreportingAny differences of opinion would have been resolved among re-viewers and where necessary referred to a fourth party for arbitra-tionThis review was conducted using standard Cochrane softwarelsquoRevman 5rsquo When data becomes available included trial data willbe processed as described in the Cochrane Reviewersrsquo handbook(Higgins 2008)

Assessment of risk of bias in included studies

If eligible studies had been identified assessment of methodolog-ical quality would have been undertaken independently by eachreviewer using the criteria described in the Cochrane Collabo-ration Handbook (Higgins 2008) Dissagreements would be re-solved through discussion The system for classifying methodolog-ical quality of controlled trials is based on the following sources ofbiasSequence generation

bull Low risk of bias (the methods used was either adequate(eg computer generated random numbers table of randomnumbers) or unlikely to introduce confounding)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to introduceconfounding)

4Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

[Intervention Review]

Single incision versus conventional multi-incisionappendicectomy for suspected appendicitis

Haroon Rehman1 Ahsan M Rao2 Irfan Ahmed3

1General Surgery University of Aberdeen Aberdeen UK 2Department of Surgery Aberdeen Royal Infirmary NHS GrampianAberdeen UK 3Department of Surgery Aberdeen Royal Infirmary Aberdeen UK

Contact address Haroon Rehman General Surgery University of Aberdeen Aberdeen Royal Infirmary Foresterhill Aberdeen ScotlandAB25 2ZD UK haroonrehman06aberdeenacuk

Editorial group Cochrane Colorectal Cancer GroupPublication status and date New published in Issue 7 2011Review content assessed as up-to-date 31 January 2011

Citation Rehman H Rao AM Ahmed I Single incision versus conventional multi-incision appendicectomy for suspected appendicitisCochrane Database of Systematic Reviews 2011 Issue 7 Art No CD009022 DOI 10100214651858CD009022pub2

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

A B S T R A C T

Background

Appendicectomy is a well established surgical procedure used in the management of acute appendicitis The operation can be performedwith minimally invasive surgery (laparoscopic) or as an open procedure A recent development in appendicectomy has been theintroduction of less invasive single incision laparoscopic surgery using a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision There are yet unanswered questions regarding the efficacy of this new and novel technique includingpatient benefit and satisfaction complications long-term outcomes and survival

Objectives

The aim of this review is to perform meta-analysis using data from available trials comparing single incision with conventional multi-incision laparoscopic appendicectomy for appendicitis in order to ascertain any differences in outcome

Search strategy

We searched the electronic databases including MEDLINEPubMed (from 1980 to December 2010) EMBASEOvid (from 1980 toDecember 2010) and CENTRAL (The Cochrane Library 2010 Issue 11) with pre-specified terms We also searched reference lists ofrelevant articles and reviews conference proceedings and ongoing trial databases

Selection criteria

Randomised or quasi-randomised controlled trials of patients with appendicitis or symptoms of appendicitis undergoing laparoscopicappendicectomy in which at least one arm involves single incision procedures and another multi-incision procedures

Data collection and analysis

There were no RCTs or prospectively controlled trials found that met the inclusion criteria

Main results

Three authors performed study selection independently

No studies that met the inclusion criteria of this review were identified Current evidence exists only the form of case-series

This review has been authored as rsquoemptyrsquo pending the results of 5 ongoing trials

1Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Authorsrsquo conclusions

No RCTs comparing single incision laparoscopic appendectomy with multi-incision surgery could be identified No definitive conclu-sions can be made at this time Well designed prospective RCTs are required in order to evaluate benefit or harm from laparoscopicsurgical approaches for appendicectomy Until appropriate data has been reported the institutional polices of healthcare providers mustbe based on the clinical judgement of experts in the field

P L A I N L A N G U A G E S U M M A R Y

Currently there is no evidence available from randomised control trials to determine whether Single Incision Laparoscopic

Surgery provides any better effect than Conventional Multi-incision Laparoscopic Surgery for appendicectomy

Laparoscopic appendicectomy is used in treating appendicitis and can be achieved using several skin incisions in the abdominal wallor more recently with a single skin incision through which instruments are introduced into the peritoneal cavity Since no randomisedcontrol trials of single incision versus conventional multi-incision laparoscopic surgery for appendicectomy could be found the efficacyand safety of the two approaches could not be analysed in this review There is a need for randomised control trials of single incisionlaparoscopic appendicectomy for appendicitis

B A C K G R O U N D

Appendicectomy refers to the surgical removal of the appendixappendicectomy is frequently performed as an emergency proce-dure in the management of a patient suffering from acute appen-dicitis a condition in which the appendix becomes inflamed Theoperation can be performed with minimally invasive surgery (la-paroscopic) or as an open procedure

A recent development in appendicectomy has been the intro-duction of less invasive Single Incision Laparoscopic Surgery us-ing a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision

Description of the condition

Appendicitis presents a lifetime risk of 7-8 and is recognizedglobally as the most common cause of acute abdominal pain (Addiss 1990)The aetiology of acute appendicitis remains poorly understoodbut is likely to be caused by luminal obstruction (Addiss 1990)Causative agents include fecalith hyperplastic lymphoid tissueforeign bodies parasitic infection and luminal obstruction due toprimary and secondary tumor Common microbial flora impli-cated in acute appendicitis include Ecoli Klebsiella Proteus andBacteriodes group (Bennion 1990 Blewett 1995 Rautio 2000)Following obstruction of the lumen continued mucus secretionsubsequently results in increased intraluminal pressure and lumi-nal distension This may culminate in thrombosis and occlusionof small blood vessels and lymph flow stasis resulting in tissue

ischaemia A damaged mucosal barrier allows bacterial invasionof the luminal wall causing transluminal inflammation (Birnbaum2000) Continued ischemia can result in appendiceal infarctionand perforation (Mason 2008)In 1886 Fitz described the signs symptoms and progression ofacute through to perforated appendicitis recommending early ap-pendicectomy for spreading peritonitis and clinical deteriorationIn 1894 McBurney defined the surgical appendicectomy and ithas since been used to significantly lower the mortality rate of thedisease (Birnbaum 2000)

Description of the intervention

Since its introduction appendicectomy has been the primary treat-ment of choice for acute appendicitis and although antibiotics dohave some established use surgery remains the treatment of choice(Hansson 2009) Today approximately 8 of the population inthe developed world can expect to undergo appendicectomy foracute appendicitis over their lifetime (Addiss 1990)The open appendicectomy procedure remained practically un-changed for over a century evolving only with the introductionof minimally invasive surgical techniques first described in 1983(Semm 1983) Possible advantages of laparoscopic techniques in-clude quicker and less painful recovery less postoperative com-plications and better cosmetic results Diagnostic tools such asultrasonography (US) and computed tomography (CT) are usedto reduce the number of negative findings at surgery (van Randen2008)

2Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Since its introduction laparoscopic appendicectomy has under-gone a number of modifications In 1998 Scheir reduced thenumber of ports used for the procedure to two (one for graspingforceps and one for scope) (Schier 1998) Today single incisionlaparoscopic surgery first proposed by Pelosi 1992 is technicallyfeasible It further minimizes the trauma of surgery and is increas-ingly being considered a safe alternative to conventional methods(Hong 2009 Meyer 2004 Rispoli 2002)Although the mortality rate as a result of appendicectomy is lessthan 05 overall complication rates are 111 and 87 forthe open and laparoscopic procedures respectively (Guller 2004)Complications include wound infection abscess formation andileus consequently resulting morbidity and increased length ofhospital stay The minimally invasive technique is reported to havea slightly higher intraabdominal abscess rate but a significantlylower wound infection rate (Sauerland 2004)

How the intervention might work

Minimally invasive surgery (laparoscopic) offers many benefitsover open surgery with a direct impact on patient recovery (Keus2006) The insult to the body (ie abdominal wall trauma) fromminimally invasive procedures is less severe than traditional opensurgery which means potential for reduced pain quicker healinglower wound complications better cosmetic results and shorterhospital stay (Sauerland 2004) Further reducing the abdominalwall trauma is the aim of single incision surgery hence furtherreducing wound complication rates and pain scores (Ates 2007)It has been reported in studies that postoperative pain is reducedwith smaller and fewer trocars (Bisgaard 2000 Bisgaard 2002Palanivelu 2008)This review will concentrate on single incision laparoscopic ap-pendicectomy comparing it with conventional minimally invasive(laparoscopic) surgery

Why it is important to do this review

The increasing variety of treatment options for appendicitis in-dicates a lack of consensus There are yet unanswered questionsregarding the efficacy of new and novel techniques including pa-tient benefit and satisfaction complications long-term outcomesand survivalProvided a sufficient number of trials of adequate quality havebeen conducted the best evidence will come from an easily acces-sible periodically updated comprehensive systematic review Itwill incorporate all available data identify best practice and alsohighlight gaps in the evidence baseWe aim to assess the outcomes for single incision versus multi-incision laparoscopic appendicectomy for appendicitis

O B J E C T I V E S

The aim of this review is to perform meta-analysis using data fromavailable trials comparing single incision laparoscopic appendicec-tomy with conventional multi-incision appendectomy for appen-dicitis

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised or quasi-randomised controlled trials of patients withappendicitis or symptoms of appendicitis undergoing laparo-scopic appendectomy in which at least one arm involves singleincision procedures and another multi-incision

Types of participants

All patients undergoing single incision or multi-incision laparo-scopic appendectomy for appendicitis diagnosed either clinicallyor with imaging will be included Studies evaluating single in-cision laparoscopic appendicectomy in children will be analysedseparately

Types of interventions

At least one arm had to include a single-incision laparoscopic ap-pendectomy procedure to treat acute or interval appendicitis re-gardless of pathology results Conventional multi-incision laparo-scopic appendectomy was the intervention with which compari-son was madeSpecific comparisons included(1) Transumbilical single incision versus conventional multi-inci-sion laparoscopic appendicectomy in adults A single trans-um-bilical skin incision is made allowing a specialised commerciallyavailable single port device to be placed through the fascia orconventional ports to be place through multiple closely-spaced in-cisions(2) Transumbilical single incision with use of specialised singleport device versus conventional multi-incision laparoscopic ap-pendicectomy in children Intervention as for (1)

Types of outcome measures

Primary outcomes

Clinical outcomes

3Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

10 Complications (rate)11 Intraoperative (rate)111 Estimated blood loss (volume ml)112 Serosal Injury to the bowel (rate)113 Intestinal perforation (rate)114 Injury to solid organs (rate)12 Early post-op (rate)121 Wound infection (rate)122 Ileus (rate)123 Intra-abdmoninal collections (rate)13 Late post-op (rate)131 Incisional herniation (rate)14 Conversion to laparoscopic (use of more than 1 additionalport site) open surgery (rate)15 Use of additional port site (rate)16 Operating time (minutes)17 30-day mortality (rate)18 Histological confirmation of appendicitis (rate)19 Negative appendicectomyPatient reported

1 Pain score postoperative (cm VAS)2 Qol3 Cosmesis

Secondary outcomes

1 Analgesia requirements (mgday)2 Incision length (cm)3 Length of hospital stay (days)4 Return to normal activities (days)5 Cost analysis

Search methods for identification of studies

Electronic searches

We searched the following electronic databases December 2010bull Cochrane Central Register of Controlled Clinical Trials

(CENTRAL)bull MEDLINE (OvidSP)bull EMBASE (OvidSP)bull WHO international trial register

The search was limited to publications after 1983 because this iswhen laparoscopic procedures were first introduced There wasno limitation based on language Please see Appendix 1 for searchstrategy

Searching other resources

The authors inspected references of all identified studies for moretrials of interest All potential studies for the review were cross ref-erenced Published abstracts from relevant conference proceedingswere hand searchedThe authors of this review contacted the first author of each in-cluded study for more information on duplicate publications oron unpublished trials

Data collection and analysis

Since no eligible studies were identified data collection and analysishave not been performed

Selection of studies

Two independent authors HR and IA reviewed the selected stud-ies independently In cases of disagreement about inclusion or ex-clusion of the study a third author AR reviewed the study and aconsensus was reached

Data extraction and management

If eligible studies had been identified data extraction would havebeen undertaken independently by two reviewers using a standardform containing pre-specified outcomes Clarification would besought where there has been potential data collection but notreportingAny differences of opinion would have been resolved among re-viewers and where necessary referred to a fourth party for arbitra-tionThis review was conducted using standard Cochrane softwarelsquoRevman 5rsquo When data becomes available included trial data willbe processed as described in the Cochrane Reviewersrsquo handbook(Higgins 2008)

Assessment of risk of bias in included studies

If eligible studies had been identified assessment of methodolog-ical quality would have been undertaken independently by eachreviewer using the criteria described in the Cochrane Collabo-ration Handbook (Higgins 2008) Dissagreements would be re-solved through discussion The system for classifying methodolog-ical quality of controlled trials is based on the following sources ofbiasSequence generation

bull Low risk of bias (the methods used was either adequate(eg computer generated random numbers table of randomnumbers) or unlikely to introduce confounding)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to introduceconfounding)

4Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Authorsrsquo conclusions

No RCTs comparing single incision laparoscopic appendectomy with multi-incision surgery could be identified No definitive conclu-sions can be made at this time Well designed prospective RCTs are required in order to evaluate benefit or harm from laparoscopicsurgical approaches for appendicectomy Until appropriate data has been reported the institutional polices of healthcare providers mustbe based on the clinical judgement of experts in the field

P L A I N L A N G U A G E S U M M A R Y

Currently there is no evidence available from randomised control trials to determine whether Single Incision Laparoscopic

Surgery provides any better effect than Conventional Multi-incision Laparoscopic Surgery for appendicectomy

Laparoscopic appendicectomy is used in treating appendicitis and can be achieved using several skin incisions in the abdominal wallor more recently with a single skin incision through which instruments are introduced into the peritoneal cavity Since no randomisedcontrol trials of single incision versus conventional multi-incision laparoscopic surgery for appendicectomy could be found the efficacyand safety of the two approaches could not be analysed in this review There is a need for randomised control trials of single incisionlaparoscopic appendicectomy for appendicitis

B A C K G R O U N D

Appendicectomy refers to the surgical removal of the appendixappendicectomy is frequently performed as an emergency proce-dure in the management of a patient suffering from acute appen-dicitis a condition in which the appendix becomes inflamed Theoperation can be performed with minimally invasive surgery (la-paroscopic) or as an open procedure

A recent development in appendicectomy has been the intro-duction of less invasive Single Incision Laparoscopic Surgery us-ing a single multi-luminal port or multiple mono-luminal portsthrough a single skin incision

Description of the condition

Appendicitis presents a lifetime risk of 7-8 and is recognizedglobally as the most common cause of acute abdominal pain (Addiss 1990)The aetiology of acute appendicitis remains poorly understoodbut is likely to be caused by luminal obstruction (Addiss 1990)Causative agents include fecalith hyperplastic lymphoid tissueforeign bodies parasitic infection and luminal obstruction due toprimary and secondary tumor Common microbial flora impli-cated in acute appendicitis include Ecoli Klebsiella Proteus andBacteriodes group (Bennion 1990 Blewett 1995 Rautio 2000)Following obstruction of the lumen continued mucus secretionsubsequently results in increased intraluminal pressure and lumi-nal distension This may culminate in thrombosis and occlusionof small blood vessels and lymph flow stasis resulting in tissue

ischaemia A damaged mucosal barrier allows bacterial invasionof the luminal wall causing transluminal inflammation (Birnbaum2000) Continued ischemia can result in appendiceal infarctionand perforation (Mason 2008)In 1886 Fitz described the signs symptoms and progression ofacute through to perforated appendicitis recommending early ap-pendicectomy for spreading peritonitis and clinical deteriorationIn 1894 McBurney defined the surgical appendicectomy and ithas since been used to significantly lower the mortality rate of thedisease (Birnbaum 2000)

Description of the intervention

Since its introduction appendicectomy has been the primary treat-ment of choice for acute appendicitis and although antibiotics dohave some established use surgery remains the treatment of choice(Hansson 2009) Today approximately 8 of the population inthe developed world can expect to undergo appendicectomy foracute appendicitis over their lifetime (Addiss 1990)The open appendicectomy procedure remained practically un-changed for over a century evolving only with the introductionof minimally invasive surgical techniques first described in 1983(Semm 1983) Possible advantages of laparoscopic techniques in-clude quicker and less painful recovery less postoperative com-plications and better cosmetic results Diagnostic tools such asultrasonography (US) and computed tomography (CT) are usedto reduce the number of negative findings at surgery (van Randen2008)

2Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Since its introduction laparoscopic appendicectomy has under-gone a number of modifications In 1998 Scheir reduced thenumber of ports used for the procedure to two (one for graspingforceps and one for scope) (Schier 1998) Today single incisionlaparoscopic surgery first proposed by Pelosi 1992 is technicallyfeasible It further minimizes the trauma of surgery and is increas-ingly being considered a safe alternative to conventional methods(Hong 2009 Meyer 2004 Rispoli 2002)Although the mortality rate as a result of appendicectomy is lessthan 05 overall complication rates are 111 and 87 forthe open and laparoscopic procedures respectively (Guller 2004)Complications include wound infection abscess formation andileus consequently resulting morbidity and increased length ofhospital stay The minimally invasive technique is reported to havea slightly higher intraabdominal abscess rate but a significantlylower wound infection rate (Sauerland 2004)

How the intervention might work

Minimally invasive surgery (laparoscopic) offers many benefitsover open surgery with a direct impact on patient recovery (Keus2006) The insult to the body (ie abdominal wall trauma) fromminimally invasive procedures is less severe than traditional opensurgery which means potential for reduced pain quicker healinglower wound complications better cosmetic results and shorterhospital stay (Sauerland 2004) Further reducing the abdominalwall trauma is the aim of single incision surgery hence furtherreducing wound complication rates and pain scores (Ates 2007)It has been reported in studies that postoperative pain is reducedwith smaller and fewer trocars (Bisgaard 2000 Bisgaard 2002Palanivelu 2008)This review will concentrate on single incision laparoscopic ap-pendicectomy comparing it with conventional minimally invasive(laparoscopic) surgery

Why it is important to do this review

The increasing variety of treatment options for appendicitis in-dicates a lack of consensus There are yet unanswered questionsregarding the efficacy of new and novel techniques including pa-tient benefit and satisfaction complications long-term outcomesand survivalProvided a sufficient number of trials of adequate quality havebeen conducted the best evidence will come from an easily acces-sible periodically updated comprehensive systematic review Itwill incorporate all available data identify best practice and alsohighlight gaps in the evidence baseWe aim to assess the outcomes for single incision versus multi-incision laparoscopic appendicectomy for appendicitis

O B J E C T I V E S

The aim of this review is to perform meta-analysis using data fromavailable trials comparing single incision laparoscopic appendicec-tomy with conventional multi-incision appendectomy for appen-dicitis

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised or quasi-randomised controlled trials of patients withappendicitis or symptoms of appendicitis undergoing laparo-scopic appendectomy in which at least one arm involves singleincision procedures and another multi-incision

Types of participants

All patients undergoing single incision or multi-incision laparo-scopic appendectomy for appendicitis diagnosed either clinicallyor with imaging will be included Studies evaluating single in-cision laparoscopic appendicectomy in children will be analysedseparately

Types of interventions

At least one arm had to include a single-incision laparoscopic ap-pendectomy procedure to treat acute or interval appendicitis re-gardless of pathology results Conventional multi-incision laparo-scopic appendectomy was the intervention with which compari-son was madeSpecific comparisons included(1) Transumbilical single incision versus conventional multi-inci-sion laparoscopic appendicectomy in adults A single trans-um-bilical skin incision is made allowing a specialised commerciallyavailable single port device to be placed through the fascia orconventional ports to be place through multiple closely-spaced in-cisions(2) Transumbilical single incision with use of specialised singleport device versus conventional multi-incision laparoscopic ap-pendicectomy in children Intervention as for (1)

Types of outcome measures

Primary outcomes

Clinical outcomes

3Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

10 Complications (rate)11 Intraoperative (rate)111 Estimated blood loss (volume ml)112 Serosal Injury to the bowel (rate)113 Intestinal perforation (rate)114 Injury to solid organs (rate)12 Early post-op (rate)121 Wound infection (rate)122 Ileus (rate)123 Intra-abdmoninal collections (rate)13 Late post-op (rate)131 Incisional herniation (rate)14 Conversion to laparoscopic (use of more than 1 additionalport site) open surgery (rate)15 Use of additional port site (rate)16 Operating time (minutes)17 30-day mortality (rate)18 Histological confirmation of appendicitis (rate)19 Negative appendicectomyPatient reported

1 Pain score postoperative (cm VAS)2 Qol3 Cosmesis

Secondary outcomes

1 Analgesia requirements (mgday)2 Incision length (cm)3 Length of hospital stay (days)4 Return to normal activities (days)5 Cost analysis

Search methods for identification of studies

Electronic searches

We searched the following electronic databases December 2010bull Cochrane Central Register of Controlled Clinical Trials

(CENTRAL)bull MEDLINE (OvidSP)bull EMBASE (OvidSP)bull WHO international trial register

The search was limited to publications after 1983 because this iswhen laparoscopic procedures were first introduced There wasno limitation based on language Please see Appendix 1 for searchstrategy

Searching other resources

The authors inspected references of all identified studies for moretrials of interest All potential studies for the review were cross ref-erenced Published abstracts from relevant conference proceedingswere hand searchedThe authors of this review contacted the first author of each in-cluded study for more information on duplicate publications oron unpublished trials

Data collection and analysis

Since no eligible studies were identified data collection and analysishave not been performed

Selection of studies

Two independent authors HR and IA reviewed the selected stud-ies independently In cases of disagreement about inclusion or ex-clusion of the study a third author AR reviewed the study and aconsensus was reached

Data extraction and management

If eligible studies had been identified data extraction would havebeen undertaken independently by two reviewers using a standardform containing pre-specified outcomes Clarification would besought where there has been potential data collection but notreportingAny differences of opinion would have been resolved among re-viewers and where necessary referred to a fourth party for arbitra-tionThis review was conducted using standard Cochrane softwarelsquoRevman 5rsquo When data becomes available included trial data willbe processed as described in the Cochrane Reviewersrsquo handbook(Higgins 2008)

Assessment of risk of bias in included studies

If eligible studies had been identified assessment of methodolog-ical quality would have been undertaken independently by eachreviewer using the criteria described in the Cochrane Collabo-ration Handbook (Higgins 2008) Dissagreements would be re-solved through discussion The system for classifying methodolog-ical quality of controlled trials is based on the following sources ofbiasSequence generation

bull Low risk of bias (the methods used was either adequate(eg computer generated random numbers table of randomnumbers) or unlikely to introduce confounding)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to introduceconfounding)

4Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Since its introduction laparoscopic appendicectomy has under-gone a number of modifications In 1998 Scheir reduced thenumber of ports used for the procedure to two (one for graspingforceps and one for scope) (Schier 1998) Today single incisionlaparoscopic surgery first proposed by Pelosi 1992 is technicallyfeasible It further minimizes the trauma of surgery and is increas-ingly being considered a safe alternative to conventional methods(Hong 2009 Meyer 2004 Rispoli 2002)Although the mortality rate as a result of appendicectomy is lessthan 05 overall complication rates are 111 and 87 forthe open and laparoscopic procedures respectively (Guller 2004)Complications include wound infection abscess formation andileus consequently resulting morbidity and increased length ofhospital stay The minimally invasive technique is reported to havea slightly higher intraabdominal abscess rate but a significantlylower wound infection rate (Sauerland 2004)

How the intervention might work

Minimally invasive surgery (laparoscopic) offers many benefitsover open surgery with a direct impact on patient recovery (Keus2006) The insult to the body (ie abdominal wall trauma) fromminimally invasive procedures is less severe than traditional opensurgery which means potential for reduced pain quicker healinglower wound complications better cosmetic results and shorterhospital stay (Sauerland 2004) Further reducing the abdominalwall trauma is the aim of single incision surgery hence furtherreducing wound complication rates and pain scores (Ates 2007)It has been reported in studies that postoperative pain is reducedwith smaller and fewer trocars (Bisgaard 2000 Bisgaard 2002Palanivelu 2008)This review will concentrate on single incision laparoscopic ap-pendicectomy comparing it with conventional minimally invasive(laparoscopic) surgery

Why it is important to do this review

The increasing variety of treatment options for appendicitis in-dicates a lack of consensus There are yet unanswered questionsregarding the efficacy of new and novel techniques including pa-tient benefit and satisfaction complications long-term outcomesand survivalProvided a sufficient number of trials of adequate quality havebeen conducted the best evidence will come from an easily acces-sible periodically updated comprehensive systematic review Itwill incorporate all available data identify best practice and alsohighlight gaps in the evidence baseWe aim to assess the outcomes for single incision versus multi-incision laparoscopic appendicectomy for appendicitis

O B J E C T I V E S

The aim of this review is to perform meta-analysis using data fromavailable trials comparing single incision laparoscopic appendicec-tomy with conventional multi-incision appendectomy for appen-dicitis

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised or quasi-randomised controlled trials of patients withappendicitis or symptoms of appendicitis undergoing laparo-scopic appendectomy in which at least one arm involves singleincision procedures and another multi-incision

Types of participants

All patients undergoing single incision or multi-incision laparo-scopic appendectomy for appendicitis diagnosed either clinicallyor with imaging will be included Studies evaluating single in-cision laparoscopic appendicectomy in children will be analysedseparately

Types of interventions

At least one arm had to include a single-incision laparoscopic ap-pendectomy procedure to treat acute or interval appendicitis re-gardless of pathology results Conventional multi-incision laparo-scopic appendectomy was the intervention with which compari-son was madeSpecific comparisons included(1) Transumbilical single incision versus conventional multi-inci-sion laparoscopic appendicectomy in adults A single trans-um-bilical skin incision is made allowing a specialised commerciallyavailable single port device to be placed through the fascia orconventional ports to be place through multiple closely-spaced in-cisions(2) Transumbilical single incision with use of specialised singleport device versus conventional multi-incision laparoscopic ap-pendicectomy in children Intervention as for (1)

Types of outcome measures

Primary outcomes

Clinical outcomes

3Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

10 Complications (rate)11 Intraoperative (rate)111 Estimated blood loss (volume ml)112 Serosal Injury to the bowel (rate)113 Intestinal perforation (rate)114 Injury to solid organs (rate)12 Early post-op (rate)121 Wound infection (rate)122 Ileus (rate)123 Intra-abdmoninal collections (rate)13 Late post-op (rate)131 Incisional herniation (rate)14 Conversion to laparoscopic (use of more than 1 additionalport site) open surgery (rate)15 Use of additional port site (rate)16 Operating time (minutes)17 30-day mortality (rate)18 Histological confirmation of appendicitis (rate)19 Negative appendicectomyPatient reported

1 Pain score postoperative (cm VAS)2 Qol3 Cosmesis

Secondary outcomes

1 Analgesia requirements (mgday)2 Incision length (cm)3 Length of hospital stay (days)4 Return to normal activities (days)5 Cost analysis

Search methods for identification of studies

Electronic searches

We searched the following electronic databases December 2010bull Cochrane Central Register of Controlled Clinical Trials

(CENTRAL)bull MEDLINE (OvidSP)bull EMBASE (OvidSP)bull WHO international trial register

The search was limited to publications after 1983 because this iswhen laparoscopic procedures were first introduced There wasno limitation based on language Please see Appendix 1 for searchstrategy

Searching other resources

The authors inspected references of all identified studies for moretrials of interest All potential studies for the review were cross ref-erenced Published abstracts from relevant conference proceedingswere hand searchedThe authors of this review contacted the first author of each in-cluded study for more information on duplicate publications oron unpublished trials

Data collection and analysis

Since no eligible studies were identified data collection and analysishave not been performed

Selection of studies

Two independent authors HR and IA reviewed the selected stud-ies independently In cases of disagreement about inclusion or ex-clusion of the study a third author AR reviewed the study and aconsensus was reached

Data extraction and management

If eligible studies had been identified data extraction would havebeen undertaken independently by two reviewers using a standardform containing pre-specified outcomes Clarification would besought where there has been potential data collection but notreportingAny differences of opinion would have been resolved among re-viewers and where necessary referred to a fourth party for arbitra-tionThis review was conducted using standard Cochrane softwarelsquoRevman 5rsquo When data becomes available included trial data willbe processed as described in the Cochrane Reviewersrsquo handbook(Higgins 2008)

Assessment of risk of bias in included studies

If eligible studies had been identified assessment of methodolog-ical quality would have been undertaken independently by eachreviewer using the criteria described in the Cochrane Collabo-ration Handbook (Higgins 2008) Dissagreements would be re-solved through discussion The system for classifying methodolog-ical quality of controlled trials is based on the following sources ofbiasSequence generation

bull Low risk of bias (the methods used was either adequate(eg computer generated random numbers table of randomnumbers) or unlikely to introduce confounding)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to introduceconfounding)

4Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

10 Complications (rate)11 Intraoperative (rate)111 Estimated blood loss (volume ml)112 Serosal Injury to the bowel (rate)113 Intestinal perforation (rate)114 Injury to solid organs (rate)12 Early post-op (rate)121 Wound infection (rate)122 Ileus (rate)123 Intra-abdmoninal collections (rate)13 Late post-op (rate)131 Incisional herniation (rate)14 Conversion to laparoscopic (use of more than 1 additionalport site) open surgery (rate)15 Use of additional port site (rate)16 Operating time (minutes)17 30-day mortality (rate)18 Histological confirmation of appendicitis (rate)19 Negative appendicectomyPatient reported

1 Pain score postoperative (cm VAS)2 Qol3 Cosmesis

Secondary outcomes

1 Analgesia requirements (mgday)2 Incision length (cm)3 Length of hospital stay (days)4 Return to normal activities (days)5 Cost analysis

Search methods for identification of studies

Electronic searches

We searched the following electronic databases December 2010bull Cochrane Central Register of Controlled Clinical Trials

(CENTRAL)bull MEDLINE (OvidSP)bull EMBASE (OvidSP)bull WHO international trial register

The search was limited to publications after 1983 because this iswhen laparoscopic procedures were first introduced There wasno limitation based on language Please see Appendix 1 for searchstrategy

Searching other resources

The authors inspected references of all identified studies for moretrials of interest All potential studies for the review were cross ref-erenced Published abstracts from relevant conference proceedingswere hand searchedThe authors of this review contacted the first author of each in-cluded study for more information on duplicate publications oron unpublished trials

Data collection and analysis

Since no eligible studies were identified data collection and analysishave not been performed

Selection of studies

Two independent authors HR and IA reviewed the selected stud-ies independently In cases of disagreement about inclusion or ex-clusion of the study a third author AR reviewed the study and aconsensus was reached

Data extraction and management

If eligible studies had been identified data extraction would havebeen undertaken independently by two reviewers using a standardform containing pre-specified outcomes Clarification would besought where there has been potential data collection but notreportingAny differences of opinion would have been resolved among re-viewers and where necessary referred to a fourth party for arbitra-tionThis review was conducted using standard Cochrane softwarelsquoRevman 5rsquo When data becomes available included trial data willbe processed as described in the Cochrane Reviewersrsquo handbook(Higgins 2008)

Assessment of risk of bias in included studies

If eligible studies had been identified assessment of methodolog-ical quality would have been undertaken independently by eachreviewer using the criteria described in the Cochrane Collabo-ration Handbook (Higgins 2008) Dissagreements would be re-solved through discussion The system for classifying methodolog-ical quality of controlled trials is based on the following sources ofbiasSequence generation

bull Low risk of bias (the methods used was either adequate(eg computer generated random numbers table of randomnumbers) or unlikely to introduce confounding)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to introduceconfounding)

4Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

bull High risk of bias (the method used (eg quasi-randomisedtrials) was inadequate and likely to introduce confounding)

Allocation concealment

bull Low risk of bias (the method used (eg central allocation)was unlikely to induce bias on the final observed effect)

bull Uncertain risk of bias (there was insufficient information toassess whether the method used was likely to induce bias on theestimate of effect)

bull High risk of bias (the method used (eg open randomallocation schedule) was likely to induce bias on the finalobserved effect)

Blinding of participants and outcome assessors for short-term

outcomes

bull Low risk of bias (blinding was performed adequately or theoutcome measurement was not likely to be influenced by lack ofblinding)

bull Uncertain risk of bias (there was insufficient information toassess whether the type of blinding used was likely to induce biason the estimate of effect)

bull High risk of bias (no blinding or incomplete blinding andthe outcome or the outcome measurement was likely to beinfluenced by lack of blinding)

Incomplete outcome data

bull Low risk of bias (the underlying reasons for missingnesswere unlikely to make treatment effects departure from plausiblevalues or proper methods had been employed to handle missingdata)

bull Uncertain risk of bias (there was insufficient information toassess whether the missing data mechanism in combination withthe method used to handle missing data was likely to induce biason the estimate of effect)

bull High risk of bias (the crude estimate of effects (egcomplete case estimate) would clearly be biased due to theunderlying reasons for missingness and the methods used tohandle missing data were unsatisfactory)

Selective outcome reporting

bull Low risk of bias (the trial protocol was available and all ofthe trialrsquos pre-specified outcomes that were of interest in thereview had been reported or similar)

bull Uncertain risk of bias (there was insufficient information toassess whether the magnitude and direction of the observedeffect was related to selective outcome reporting)

bull High risk of bias (not all of the trialrsquos pre-specified primaryoutcomes have been reported or similar)

Baseline imbalance

bull Low risk of bias (there was no baseline imbalance inimportant characteristics)

bull Uncertain risk of bias (the baseline characteristics were notreported)

bull High risk of bias (there was an baseline imbalance due tochance or due to imbalanced exclusion after randomisation)

Early stopping

bull Low risk of bias (the sample size calculation was reportedand the trial was not stopped or the trial was stopped early byformal stopping rules at a point where the likelihood ofobserving an extreme intervention effect due to chance was low)

bull Uncertain risk of bias (sample size calculation was notreported and it was not clear whether the trial was stopped earlyor not)

bull High risk of bias (the trial was stopped early due toinformal stopping rules or the trial was stopped early by a formalstopping rule where the likelihood of observing an extremeintervention effect due to chance was high)

Vested interest bias

bull Low risk of bias (there was no risk of vested interests on theside of researchers manufacturers or funding bodies or anypersonal conflicts by the authors of the trial publication thatmight have unduly influenced judgements were disclosed in anhonest and upright manner)

bull Uncertain risk of bias (it was not possible to say that therewere or were not any financial interests on the side of theresearchers manufacturers or funding bodies reported in thetrial publications)

bull High risk of bias (there was risk for vested interests forexample the trial was funded by a drug manufacturer orresearchers had received money for the performance of the trialand interests like these could have influenced the results of thetrial report)

Expertise Bias

bull Low risk of bias (the surgeons had equal expertise in bothlaparoscopic surgery techniques)

bull Uncertain risk of bias (the expertise of the surgeons in eachparticular technique was not mentioned)

bull High risk of bias (the surgeons had different expertise forlaparoscopic techniques)

Other bias

bull Low risk of bias (the trial appears to be free of othercomponents that could put it at risk of bias)

bull Uncertain risk of bias (the trial may or may not have beenfree of other components that could have put it at risk of bias)

bull High risk of bias (there are other factors in the trial thatcould put it at risk of bias eg for-profit involvement authorshave conducted trials on the same topic etc)

However since no eligible studies were identified the assessmentof the risk of bias was not applicable

5Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Measures of treatment effect

If eligible studies had been identified where possible a combinedestimate of treatment effect across similar studies would have beencalculated for each pre-specified outcome Relative risks wouldhave been used for categorical (dichotomous) data and weightedmean differences for continuous outcomes with 95 confidenceintervals generated where possible A fixed effects approach to theanalysis would have been undertaken unless there is evidence ofheterogeneity across studies

Dealing with missing data

In future reviewers will contact authors of trials to obtain anymissing data

Assessment of heterogeneity

When data becomes available a Chi-aquare test will be used as wellas visual inspection of graphs and assessment of I-squared statisticto investigate the possibility of heterogeneity A significance levelless than 010 will be interpreted as evidence of heterogeneityIf there is no obvious reason for the heterogeneity (after consider-ation of populations interventions outcomes and setting of theindividual trials) or it persists despite the removal of outlying tri-als a random effects model will be used

Assessment of reporting biases

Publication bias in future analysis will be examined by FunnelPlot if feasible

Data synthesis

If meta-analysis were possible the Mantel Haenszel statisticalmethod would have been used A fixed approach to the analysiswould have been undertaken unless there was evidence of het-erogeneity across studies in which case the random effects modelwould have been used

Subgroup analysis and investigation of heterogeneity

A subgroup analysis would have been performed for the varioustypes of single incision technique reported (single skin incisionwith single fascial incision using special multi-luminal port versussingle skin incision with multiple closely spaced fascial incisionsusing conventional ports) Subgroup analysis would also wherepossible have been performed on status (perforated or not) andlocation (retrocaecal or pelvic) of the appendix

Sensitivity analysis

A sensitivity analysis would have been performed to compare stud-ies for their inclusion criteria variation in technique used andstudy design

R E S U L T S

Description of studies

See Characteristics of excluded studies Characteristics of ongoingstudies

Results of the search

Characteristics of excluded studies Characteristics of ongoingstudiesThe electronic search yielded 77 distinct titles up to December2010 55 of which appeared potentially relevant and were re-trieved but subsequently failed to meet inclusion criteria No ran-domised control trials were identified with arms comparing SingleIncision Laparoscopic Surgery and Conventional Multi-incisionLaparoscopic Surgery A comprehensive search for observationalstudies was not conducted Although it was not the objective ofthe systematic search observational and non-randomised studiesknown to the authors are cited in the characteristics of excludedstudiesScanning the reference lists of relevant studies and reviews andscanning several major conference proceedings (including SAGESASCO DDW ASCRS ASGBI and EAES) did not identify anyother eligible studiesFive ongoing trials were identified (see Characteristics of ongoingstudies)

Risk of bias in included studies

We did not identify any suitable trials for inclusion

Effects of interventions

There are currently no appropriate studies for inclusion and there-fore effects of intervention have not been reported

D I S C U S S I O N

Summary of main results

The relationship between endosurgical approaches has been thesubject of much debate in recent years Appendicectomy is a com-mon procedure and thus lends itself suitably for comparison ofsurgical techniques Some clinicians believe single incision laparo-scopic surgery may be embraced over other novel surgical inno-vations such as natural orifice transluminal endoscopic surgeryin light of fact that it is based on current practice incision in

6Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

proximity to the umbilicus laparoscopic instruments and cameraproviding access and viewCurrent literature describes three broad single incision laparo-scopic techniques A single skin incision with single facial inci-sion to place a special or improvised single port device throughwhich special or conventional laparoscopic instruments can be in-troduced into the peritoneal cavity A single skin incision withmultiple closely spaced fascial incisions through which specialor conventional laparoscopic instruments can be introduced Aldquohybridrdquo approach with conventional open appendicectomy tech-nique being used to divide an appendix which has been exteri-orised using a trans-umbilical single-incision laparoscopically-as-sisted operationSome of the shortcomings of the excluded studies were failure torandomise patients widespread omission of outcome related datafailure to adequately report study design and failure to includeappropriate control armsThe aim of this review was to meta-analyse data from prospec-tive randomised trials reporting on the effectiveness and safety ofSingle-Incision Laparoscopic Surgery for appendicitis Unfortu-nately no such study yet exists The best available evidence iscurrently only available from observational studies retrospectiveor prospective case series with or without control

A U T H O R S rsquo C O N C L U S I O N S

Implications for practice

At the time of authoring this review reliable conclusions can not bedrawn on the effectiveness of Single Incision Laparoscopic Surgeryversus conventional multi-incision laparoscopic surgery due tothe lack of available evidence Until appropriate data has beenreported the institutional polices of healthcare providers must bebased on the clinical judgement of experts in the field

Implications for research

Well designed prospective RCTs of adequate power and appro-priate randomisation of patients are urgently required in order toevaluate benefit or harm from laparoscopic surgical approachesOutcomes of clinical significance should be measured and reportedin a standardized to enable data extraction for subsequent meta-analysis

A C K N O W L E D G E M E N T S

We are grateful for the advice and support Henning Keinke Ander-sen Managing Editor of the Cochrane Colorectal Cancer Groupfor his continued advice and support throughout the review pro-cess

R E F E R E N C E S

References to studies excluded from this review

Akgr 2010 published data only

Akgr F Olguner M Hakgder G Ate O Appendectomyconducted with Single Port Incisionless-IntracorporealConventional Equipment-Endoscopic Surgery J Pediatr

Surg 201045(5)1061ndash3

Ate 2007 published data only

Ate O Hakgder G Olguner M Akgr F Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Barbaros 2010 published data only

Barbaros U Smer A Tunca F Gzkn O Demirel T Bilge Oet alOur early experiences with single-incision laparoscopicsurgery the first 32 patients Surg Laparosc Endosc Percutan

Tech 201020(5)306ndash11

Chandler 2010 published data only

Chandler N Danielson P Single-incision laparoscopicappendectomy vs multiport laparoscopic appendectomy inchildren a retrospective comparison J Pediatr Surg 201045(11)2186ndash90

Chouillard 2010 published data only

Chouillard E Dache A Torcivia A Helmy N Ruseykin IGumbs A Single-incision laparoscopic appendectomy foracute appendicitis a preliminary experience Surg Endosc

2010241ndash5

Chow 2009 published data only

Chow A Purkayastha S Paraskeva P Appendicectomy andcholecystectomy using single-incision laparoscopic surgery(SILS) the first UK experience Surg Innov 200916(3)211ndash7

Chow 2010 published data only

Chow A Purkayastha S Nehme J Darzi L Paraskeva PSingle incision laparoscopic surgery for appendicectomy aretrospective comparative analysis Surg Endosc 201024

(10)2567ndash74

DrsquoAlessio 2002 published data only

DrsquoAlessio A Piro E Tadini B Beretta F One-trocartransumbilical laparoscopic-assisted appendectomy inchildren our experience Eur J Pediatr Surg 200212(1)24ndash7

Dapri 2002 published data only

Dapri G Casali L Dumont H Van der Goot L HerrandouL Pastijn E et alSingle-access transumbilical laparoscopic

7Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

appendectomy and cholecystectomy using new curvedreusable instruments a pilot feasibility study Surg

Endosc July 201025(4)1325ndash32 [DOI 101007s00464-010-1304-7]

Dutta 2009 published data only

Dutta S Early experience with single incision laparoscopicsurgery eliminating the scar from abdominal operations J

Pediatr Surg 200944(9)1741ndash5

Esposito 1998 published data only

Esposito C One-trocar appendectomy in pediatric surgerySurg Endosc 199812(2)177ndash178

Guan 2010 published data only

Guan R Gesmundo R Maiullari E Bianco ER Bucci VFerrero L et alTreatment of acute appendicitis with one-port transumbilical laparoscopic-assisted appendectomy asix-year single-centre experience Afr J Paediatr Surg 20107(3)169ndash73

Hong 2009a published data only

Hong ZJ Fan HL Kuo SM Chen TW Chan DC Liu YCet alPreliminary Report of One-port Laparoscopy-assistedExtracorporeal Appendectomy in Adult Appendicitis J Med

Sci 200929(3)135ndash138

Hong 2009b published data only

Hong T Kim H Lee Y Kim J Lee K You Y etalTransumbilical single-port laparoscopic appendectomy(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Hussain 2009 published data only

Hussain A El-Hasani S Transumbilical laparoscopicallyassisted appendectomy in children Surg Endosc 200923(4)912

Inoue 1994 published data only

Inoue H Takeshita K Endo M Single-port laparoscopyassisted appendectomy under local pneumoperitoneumcondition Surgical Endosc 19948(6)714ndash6

Jyrki 2010 published data only

Jyrki K Initial Experience of the Feasibility of Single-Incision Laparoscopic Appendectomy in Different ClinicalConditions Diagnostic and Therapeutic Endoscopy 2010[DOI 1011552010240260]

Kala 1996 published data only

Kala Z Hanke I Neumann C A modified technic inlaparoscopy-assisted appendectomy--a transumbilicalapproach through a single port Rozhl Chir 199675(1)15ndash18

Kim 2009 published data only

Kim HJ Lee JI Lee YS Lee IK Park JH Lee SK etalSingle-port transumbilical laparoscopic appendectomy43 consecutive cases Surg Endosc Nov 201024(11)2765ndash9 [DOI 101007s00464-010-1043-9]

Kim 2009b published data only

Kim JW Park JS Chang IT Choi YS Song HJ Kim BGThe initial experience with a single incision laparoscopicappendectomy J Korean Soc Coloproctol 200925(5)312ndash317

Koontz 2006 published data only

Koontz C Smith L Burkholder H Higdon K AderholdR Carr M Video-assisted transumbilical appendectomy inchildren J Pediatr Surg 200641(4)710ndash2

Lee Yoon 2009 published data only

Lee Y Kim J Moon E Kim J Lee K Oh S et alComparativestudy on surgical outcomes and operative costs oftransumbilical single-port laparoscopic appendectomyversus conventional laparoscopic appendectomy in adultpatients Surg Laparo Endosc Per Tech 200919(6)493ndash6

Lee 2010 published data only

Lee JA Sung KY Lee JH Lee DS LaparoscopicAppendectomy with a Single Incision in a Single Institute J

Korean Soc Coloproctol 201026(4)260ndash264

Lee J 2010 published data only

Lee J Baek J Kim W Laparoscopic transumbilical single-port appendectomy initial experience and comparison withthree-port appendectomy Surg Laparo Endosc Per Tech

201020(2)100ndash3

Lee SY 2010 published data only

Lee SY Lee HM Hsieh CS Chuang JH Transumbilicallaparoscopic appendectomy for acute appendicitis areliable one-port procedure Surg Endosc Aug 201025(4)1115ndash1120

Martinez 2007 published data only

Martinez AP Bermejo MA Corts JC Orayen CG ChaconJP Bravo LB Appendectomy with a single trocar throughthe umbilicus results of our series and a cost approximationCir Pediatr 200720(1)10ndash14

Meyer 2004 published data only

Meyer A Preuss M Roesler S Lainka M OmlorG Transumbilical laparoscopic-assisted ldquoone-trocarrdquoappendectomy -- TULAA -- as an alternative operationmethod in the treatment of appendicitis Zentralbl Chir

2004129(5)391ndash395

Min 2009 published data only

Min IC Kim DJ Jang LC Choi JW Sun WY Jeong JS etalSingle Incision Three Ports Laparoscopic AppendectomyJournal of the Korean Society of Endoscopic amp Laparoscopic

Surgeons 200912(2)84ndash87

Muensterer published data only

Muensterer OJ Puga Nougues C Adibe OO Amin SRGeorgeson KE Harmon CM Appendectomy using single-incision pediatric endosurgery for acute and perforatedappendicitis Surg Endosc 2010243201-3204 [DOI101007s00464-010-1115-x]

Palanivelu 2008 published data only

Palanivelu C Rajan P Rangarajan M Parthasarathi RSenthilnathan P Praveenraj P Transumbilical endoscopicappendectomy in humans on the road to NOTES aprospective study J Laparoendosc Adv Surg Tech 200818

(4)579ndash82

Pappalepore 2002 published data only

Pappalepore N Tursini S Marino N Lisi G ChiesaPL Transumbilical laparoscopic-assisted appendectomy

8Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(TULAA) a safe and useful alternative for uncomplicatedappendicitis Eur J Pediatr Surg 200212(6)383ndash6

Park 2010 published data only (unpublished sought but not used)

Park JH Hyun KH Park CH Choi SY Choi WHKim DJ et alLaparoscopic vs Transumbilical Single-Port Laparoscopic Appendectomy Results of ProspectiveRandomized Trial J Kor Surg Soc 201078(4)213ndash218

Petnehazy 2010 published data only

Petnehazy T Saxena A Ainoedhofer H Hoellwarth MESchalamon J Singleport appendectomy in obese childrenan optimal alternative Acta Paeligdiatrica 201099(9)1370ndash1373

Ponsky 2009 published data only

Ponsky TA Diluciano J Chwals W Parry R BoulangerS Early experience with single-port laparoscopic surgeryin children J Laparoendosc Adv Surg Tech 200919(4)551ndash553

Rao 2004 published data only

Rao MM Rao RKM Two-port and single port laparoscopicappendicectomy J Indian Med Assoc 2004102(7)360ndash364

Rispoli 2002 published data only

Rispoli G Armellino MF Esposito C One-trocarappendectomy Surg Endosc 200216(5)833ndash5

Roberts 2009 published data only

Roberts K True single-port appendectomy first experiencewith the ldquopuppeteer techniquerdquo Surg Endosc 200923(8)1825ndash30

Rothenberg 2009 published data only

Rothenberg SS Shipman K Yoder S Experience withmodified single-port laparoscopic procedures in children J

Laparoendosc Adv Surg Tech A 200919(5)695ndash698

Saber 2010 published data only

AA Elgamal MH El-Ghazaly TH Dewoolkar AV AklA Simple technique for single incision transumbilicallaparoscopic appendectomy Int J Surg 20108(2)128ndash130

Satomi 2001 published data only

Satomi A Tanimizu T Takahashi S Kawase H MuraiH Yonekawa H et alOne-Port Laparoscopy-AssistedAppendectomy in Children with Appendicitis Experiencewith 100 Cases Pediatr Endosurg Innov Tech 20015(4)371ndash377

Sesia 2010 published data only

Sesia SB Haecker FM Kubiak R Mayr J Laparoscopy-Assisted Single-Port Appendectomy in Children Is thePostoperative Infectious Complication Rate Different J

Laparoendosc Adv Surg Tech 201020(10)59ndash64

Tam 2010 published data only

Tam YH Lee KH Sihoe JDY Chan KW Cheung ST PangKKY A Surgeon-Friendly Technique to Perform Single-Incision Laparoscopic Appendectomy Intracorporeally inChildren with Conventional Laparoscopic Instruments J

Laparoendosc Adv Surg Tech 201020(6)577ndash580

Valla 1999 published data only

Valla J Ordorica-Flores RM Steyaert H Merrot T BartelsA Breaud J et alUmbilical one-puncture laparoscopic-

assisted appendectomy in children Surg Endosc 199913(1)83ndash5

Varshney 2007 published data only

Varshney S Sewkani A Vyas S Sharma S Kapoor S NaikS et alSingle-port transumbilical laparoscopic-assistedappendectomy Indian J Gastroent 200726(4)192

Vidal 2010 published data only

Vidal Oacute Ginestagrave C Valentini M Martiacute J BenarrochG Garciacutea-Valdecasas JC Suprapubic single-incisionlaparoscopic appendectomy a nonvisible-scar surgicaloption Surg Endosc July 201025(4)1019ndash1023 [DOI101007s00464-010-1307-4]

Visnjic 2008 published data only

Visnjic S Transumbilical laparoscopically assistedappendectomy in children high-tech low-budget surgerySurg Endosc 200822(7)1667ndash71

References to ongoing studies

Ahmed 2011 unpublished data only

Ahmed I Personal correspondence February 22 2011

Carter 2010 unpublished data only

Carter J Personal correspondence March 4 2011Carter J Single-incision Laparoscopic (SILS) VersusConventional Laparoscopic Appendectomy for theTreatment of Acute Appendicitis httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00997516]

Kay Yau 2009 unpublished data only

Kay Yau K Transumbilical Single Incision VersusConventional Three Incisions LaparoscopicAppendicectomy httpclinicaltrialsgov (accessed 040311) 2009 [ NCT01024439]

St Peter 2009 unpublished data only

St Peter S Personal Correspondence March 2 2011St Peter S Single Incision Laparoscopic Surgery (SILS)Versus Laparoscopic Appendectomy httpclinicaltrialsgov(accessed 040311) 2009 [ NCT00981136]

Teoh 2009 unpublished data only

Teoh A Personal Correspondence March 2 2011Teoh A Single-site Access Versus Conventional Three-portLaparoscopic Appendectomy httpclinicaltrialsgov 2010[ NCT01203566]

Additional references

Addiss 1990

Addiss DG Shaffer N Fowler BS Tauxe RV Theepidemiology of appendicitis and appendectomy in theUnited States Am J Epidemiol Apr 1990132(5)910

Ates 2007

Ates O Hakguumlder G Olguner M Akguumlr FM Single-portlaparoscopic appendectomy conducted intracorporeallywith the aid of a transabdominal sling suture J Pediatr Surg

200742(6)1071ndash4

Bennion 1990

Bennion RS Baron EJ Thompson Jr JE DownesJ Summanen P Talan DA et alThe bacteriology of

9Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

gangrenous and perforated appendicitis--revisited Ann

Surg Feb 1990211(2)165

Birnbaum 2000

Birnbaum BA Wilson SR Appendicitis at the millenniumRadiology May 2000215337ndash48

Bisgaard 2000

Bisgaard T Klarskov B Trap R Kehlet H Rosenberg JPain after microlaparoscopic cholecystectomy Surg Endosc

200014(4)340ndash4

Bisgaard 2002

Bisgaard T Klarskov B Trap R Kehlet H RosenbergJ Microlaparoscopic vs conventional laparoscopiccholecystectomy Surg Endosc 200216(3)458ndash64

Blewett 1995

Blewett CJ Krummel TM Perforated appendicitis pastand future controversies Semin Pediatr Surg 1995 Vol 4234

Guller 2004

Guller U Hervey S Purves H Muhlbaier LH Peterson EDEubanks S et alLaparoscopic versus open appendectomyoutcomes comparison based on a large administrativedatabase Ann Surg 2004239(1)43

Hansson 2009

Hansson J Koumlrner U Khorram Manesh A Solberg ALundholm K Randomized clinical trial of antibiotictherapy versus appendicectomy as primary treatment ofacute appendicitis in unselected patients Brit J Surg April200996(5)473ndash81

Higgins 2008

Higgins JTP Green S Cochrane handbook for systematic

reviews of interventions Wiley Online Library 2008

Hong 2009

Hong TH Kim HL Lee YS Kim JJ Lee KH You YK etalTransumbilical single-port laparoscopic appendectomy

(TUSPLA) scarless intracorporeal appendectomy J

Laparoendosc Adv Surg Tech 200919(1)75ndash8

Keus 2006

Keus F De Jong J Gooszen HG Laarhoven C Laparoscopicversus open cholecystectomy for patients with symptomaticcholecystolithiasis Cochrane Database of Systematic Reviews

2006 Issue 1 [DOI 10100214651858CD006231]

Mason 2008

Mason RJ Surgery for appendicitis is it necessary Surg

Infect Aug 20089(4)481ndash8

Pelosi 1992

Pelosi MA Pelosi 3rd MA Laparoscopic appendectomyusing a single umbilical puncture (minilaparoscopy) J

Reprod Med 199237(7)588

Rautio 2000

Rautio M Bacteriology of histopathologically definedappendicitis in children Pediatr Infect Dis November 200019(11)1078

Sauerland 2004

Sauerland S Lefering R Neugebauer EA Laparoscopicversus open surgery for suspected appendicitis Cochrane

Database of Systematic Reviews 200446699ndash701

Schier 1998

Schier F Laparoscopic appendectomy with 17-mminstruments Pediatr Surg Int 199814(1)142ndash3

Semm 1983

Semm K Endoscopic appendectomy Endoscopy 198315

(2)59ndash64

van Randen 2008

van Randen A Bipat S Zwinderman AH Ubbink DTStoker J Boermeester MA Acute Appendicitis Meta-Analysis of Diagnostic Performance of CT and GradedCompression US Related to Prevalence of Disease1Radiology 2008249(1)97

lowast Indicates the major publication for the study

10Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Akgr 2010 Case series

Ate 2007 Case series (historic controls)

Barbaros 2010 Case Series

Chandler 2010 Case series

Chouillard 2010 Case series

Chow 2009 Case series

Chow 2010 Non-randomised retrospective comparative analysis

DrsquoAlessio 2002 Case series

Dapri 2002 Case series

Dutta 2009 Case series

Esposito 1998 Case series

Guan 2010 Case series

Hong 2009a Case series

Hong 2009b Case series

Hussain 2009 Letter

Inoue 1994 Case series

Jyrki 2010 Case series

Kala 1996 Case series

Kim 2009 Case series

Kim 2009b Case series

Koontz 2006 Case series

Lee Yoon 2009 Non-randomised retrospective comparative analysis

11Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Lee 2010 Case Series

Lee J 2010 Non-randomised retrospective comparative analysis

Lee SY 2010 Non-randomised retrospective comparative analysis

Martinez 2007 Case series (historic control using open appendicectomy)

Meyer 2004 Case series

Min 2009 Case series

Muensterer Case series

Palanivelu 2008 Case series

Pappalepore 2002 Non-randomised retrospective comparative analysis of open appendicectomy versus single incision laparoscopicappendicectomy

Park 2010 Inadequate description of methods

Petnehazy 2010 Non-randomised retrospective comparative analysis of single incision laparoscopic appendicectomy in obeseversus normal weight children

Ponsky 2009 Case series

Rao 2004 Case series

Rispoli 2002 Case series

Roberts 2009 Case series

Rothenberg 2009 Case series

Saber 2010 Case series

Satomi 2001 Case series

Sesia 2010 Retrospective study of infection rate in those patient undergoing single incision laparoscopic appendicectomy

Tam 2010 Case series

Valla 1999 Case series

Varshney 2007 Letter

Vidal 2010 Case series

12Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

(Continued)

Visnjic 2008 Case series

Characteristics of ongoing studies [ordered by study ID]

Ahmed 2011

Trial name or title Single portincision laparoscopic surgery compared with standard 3 port laparoscopic surgery

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 60Inclusion Criteria

bull Aged 16 or overbull suspected appendicitisbull laparoscopic surgery appropriate

Exclusion Criteriabull Abdmoinal surgery through midline incisionbull Umbilical hernia repair with meshbull Patient unable to co sent

Interventions Intervention Single port laparoscopic appendicectomy

A single intra-umbilical incision will be made and a multi-chanel port or three conventional trocars willbe inserted A 5 or 10 mm 30 degree telescope will be used to visualise the operative field Conventionallaparoscopic instruments will be used for the procedure Roticulating curved instruments will be availableand used if required Use of any additional instruments or ports will be recorded for the cost analysis Themusculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbable sutures beforeclosing the skin incisionControl Standard 3 port laparoscopic appendicectomy

Pneuomoperitoneum will be established by an open technique through an intrasupra umbilical incision witha 10-12 mm port for initial pneumoperitoneum and inspection A further 5 or 10 mm port will be used inthe left iliac fossa (depending on the availability of 5 mm laparoscopes) and a 5 mm port will be used inthe hypogastrium Standard laparoscopic instruments will be used for the procedure as per existing hospitalprotocol The musculo-aponeurotic layers of port sites of 10mm and over will be closed with absorbablesutures before closing the skin

Outcomes Patient reported outcomesbull Body Image Questionnaire (primary outcome)bull Hospital Experience Questionnairebull Pain assessment (Brief Pain Inventory Pain VAS scale Use of analgesics) (primary outcome)bull Time to return usual activitiesbull Hospital re-admissions

Clnical outcomes

13Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Ahmed 2011 (Continued)

bull Analgesic usebull Complications (Infections port-site hernia) (primary outcome)bull Conversionbull Operating timebull Theatre timebull Usage of equipmentbull Feasibility measuresbull the number of eligible patientsbull the number of patients approached and proportion of those patients who accept randomisationbull the proportion of those recruited with a complete data set at six weeks following surgerybull surgeonrsquos perceptions of the two approaches

Starting date January 2011

Contact information Irfan Ahmed FCPS MD FRCS 01224 555056 (irfanahmed2nhsnet)Aberdeen Royal Infirmary Aberdeen Scotland United Kindgom

Notes No publications provided

Carter 2010

Trial name or title A Randomized Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional LaparoscopicAppendectomy for the Treatment of Acute Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Safety Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Estimated Enrollment 150Inclusion Criteria

bull Suspected acute appendicitis on clinical and radiographic (CT) groundsExclusion Criteria

bull Phlegmon mass peri-appendiceal abscess or diffuse peritonitisbull Prior open laparotomy with incision through the umbilicusbull Body Mass Index gt 35bull Age lt18 yearsbull Mental illness dementia or inability to provide informed consentbull Chronic pain requiring daily medication (including opiate and NSAIDs)bull Pregnancybull Alternative diagnosis found by diagnostic laparoscopy (post-randomization)

Interventions Intervention SILS appendicectomyUse of SILSPort to perform laparoscopic appendicectomy in a population consisting of patients who cometo the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis ofclinical evaluation and CT of the abdomenpelvis

14Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Carter 2010 (Continued)

Control conventional laparoscopic appendicectomyConventional laparoscopic removal of the appendix in a population consisting of patients who come to theemergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinicalevaluation and CT of the abdomenpelvis

Outcomes Primary Outcome Measures

bull Pain in the first 12 hours after surgerySecondary Outcome Measures

bull Operative time - defined as the amount of time from skin-incision to application of the dressingbull Conversion - defined by the use of additional incisions andor trocarsbull Visceral or vascular injury defined - defined as injury to the intestines colon omentum vasculature or

pelvic organs during the dissection requiring intervention (suture or stapled repair use of haemostaticagents)

bull Mean pain score over 12 hours - Pain will be scored on a scale of 0-10bull Length of stay - defined as the number of calendar days the patient is hospitalisedbull Wound infection - defined as the need for additional antibiotics prescribed beyond the perioperative

antibiotics given for acute appendicitis for the purpose or treating a wound cellulitisbull Deep space infection - defined the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 6 months of surgery All intra-abdominal abscesses are classified as deepspace infections

bull Wound seroma - defined as an un-inflamed fluid collection under the skin incision gt 1cm in diameteridentified within 6 months of surgery

bull Time to return to work - defined as the number of calendar days between discharge from the hospitaland the first day back at work

bull Readmission with 30 daysbull Body Image Score at 6 monthsbull Cosmetic Appearance Scale at 6 monthsbull Photo Series Questionnaire at 6 months

Starting date May 2010

Contact information Jonathan T Carter MD 415-476-0974 (jonathancarterucsfmedctrorg)Hobart W Harris MD 415 353-2161 (hobartharrisucsfmedctrorg)UCSF Medical Center San Francisco California United States

Notes Sponsors and CollaboratorsUniversity of California San FranciscoCovidienAdditional Information Covidien SILSPort web site httpwwwsilscom

Kay Yau 2009

Trial name or title Double Blinded Randomized Controlled Study of Conventional Laparoscopic Appendicectomy Versus Tran-sumbilical Single Incision Laparoscopic Appendicectomy

Methods Allocation RandomizedControl Active ControlEndpoint Classification SafetyEfficacy Study

15Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Kay Yau 2009 (Continued)

Intervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

Participants Estimated Enrollment 80Inclusion Criteria

bull Patients will be at least 18 years of agebull Male or female (excluding pregnant females)bull Patients with ASA lt 3bull Patients informed about the study and will have read understood and signed the patient informed

consent Patients will be willing and able to submit to postoperative follow-up evaluationsExclusion Criteria

bull Patients have previous history of abdominal surgerybull Patients with ASA gt 3bull Patients with any conditions that were not suspected preoperatively and are only discovered at the time

of the operationbull Patients who are incompetent in giving consent

Interventions Intervention Transumbilical Single Incision Laparoscopic Appendicectomy

A single incision is made on umbilicus within the margin of umbilical skin ring Peritoneal cavity is enteredby open method and the fascia layer can be extended up to 25cm in length A single incision laparoscopicdevice (Olympus) will be inserted Conventional laparoscopic instruments will be used Umbilical fascia willbe closed by PDS-1 J-shape needle Marcain 05 should be infiltrated into the fascial layers as well as theskin layers with dosage up to 20ml The umbilicus is reconstructed by interrupted 3-0 nylon by tackingthe skin onto the fascia layersThree non-transparent dressings will be placed as if conventional laparoscopicappendicectomy has been doneControl Conventional Laparoscopic Appendicectomy

A 10-mm subumbilical port will be inserted by open method Two 5-mm working ports will be inserted underlaparoscopic view at patientrsquos left lower quadrant and suprapubic area Umbilical fascia will be closed by PDS-1 J-shape needleLocal anaesthetic agent Marcain 05 should be infiltrated into the fascial layers as wellas the skin layers with dosage up to 20ml All skin wound will be approximated with 3-0 nylon interruptedstitches and covered with non-transparent dressings

Outcomes Primary Outcome Measures

bull wound infection rateSecondary Outcome Measures

bull cosmetic satisfaction

Starting date October 2009

Contact information Chi wai Ho MSc in Health Care (Nursing) 25956907 ext 25956909(hocw1haorghk)Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong China 852

Notes

16Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

St Peter 2009

Trial name or title Official Title Single Incision Versus Standard Laparoscopic appendicectomy for Non-Perforated Appendicitis

Methods Allocation RandomizedControl Active ControlEndpoint Classification Efficacy StudyIntervention Model Parallel AssignmentMasking Open LabelPrimary Purpose Treatment

Participants Inclusion Criteriabull Children under 18 yearsbull Non-perforated appendicitis

Exclusion Criteriabull Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Interventions Intervention Single Incision Laparoscopic appendicectomya single incision in the umbilicus is all that will be used to remove the appendix The specific methods (stapletieport useetc) will vary depending on surgeonInterventionControl 3 port laparoscopic appendicectomyStandard laparoscopic appendicectomy with 3 ports and intracorporeal staplingIntervention

Outcomes Primary Outcome Measures

bull Post-operative infectionSecondary Outcome Measures

bull Doses of analgesicbull Operative timebull Cosmetic scoresbull Length of Hospitalizationbull Surgeon perception of difficultybull Hospitaloperative charges

Starting date August 2009

Contact information Shawn D St Peter MD 816 983 6479 ext 6465 (sspetercmhedu)Susan W Sharp PhD 816 983 6670 ext 6670 (swsharpcmhedu)Childrenrsquos Mercy Hospital Kansas City Missouri United States

Notes

Teoh 2009

Trial name or title Single-site Access Versus Conventional Three-port Laparoscopic appendicectomy A Randomized ControlledTrial

Methods Allocation RandomizedEndpoint Classification SafetyEfficacy StudyIntervention Model Parallel AssignmentMasking Double Blind (Subject Outcomes Assessor)Primary Purpose Treatment

17Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

Participants Estimated Enrollment 200Inclusion Criteria

bull History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrantbull Fever le 38degC andor WCC gt 10 X 103 cells per mLbull Right lower quadrant guarding and tenderness on physical examinationbull All patients included will be 18-75 years old

Exclusion Criteriabull Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable

to urinary or gynaecological problems)bull History of symptoms gt 5 days andor a palpable mass in the right lower quadrant suggesting an

appendiceal abscess treated with antibiotics and possible percutaneous drainagebull Patients with the following conditions are also excluded history of cirrhosis and coagulation disorders

generalized peritonitis shock on admission previous abdominal surgery ascites suspected or provenmalignancy contraindication to general anesthesia (severe cardiac andor pulmonary disease) inability togive informed consent due to mental disability and pregnancy

Interventions Intervention Single site access laparoscopic appendicectomyTwo 5 mm ports and a 10mm port will be inserted through a 13mm transumbilical incision Exploratorylaparoscopy will be carried out first to locate the appendix and to rule out other pathologies Retraction ofthe appendix will be performed with a flexible curved forceps The mesoappendix will be divided with theultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will be ligated between twopolydioxanone suture loops The specimen will be delivered within a plastic bag via the subumbilical portPurulent fluid will be irrigated and suctioned from the subhepatic space right lower quadrant and the pelvisif present Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O absorbablesubcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscesses or gangreneControlConventional 3-port laparoscopic appendicectomyLaparoscopic appendicectomy will be performed with the standard 3-port technique The laparoscope isintroduced via a 10mm subumbilical port Dissection will be performed with a 5mm LLQ port and a5mm RLQ port Other pathologies will be excluded with explorative laparoscopy The mesoappendix willbe divided with the ultrasonic dissector (Sonosurg Olympus surgical Tokyo Japan) The appendix will beligated between two polydioxanone suture loops The specimen will be delivered within a plastic bag viathe subumbilical port Purulent fluid will be irrigated and suctioned from the subhepatic space right lowerquadrant and the pelvis if present Fascial defects will be closed with 2-O polydioxanone sutures and skinclosed with 4-O absorbable subcuticular sutures A pelvic drain (12Fr) will be inserted in cases of abscessesor gangrene

Outcomes Primary Outcome Measures

bull Overall pain score experienced by the patient within the last 24 hrs (visual analogue scale)Secondary Outcome Measures

bull Conversion - defined by the use of addition incisions andor trocarsbull Operative time - defined as skin-incision to application of the dressingbull Wound infection - defined as presence of skin erythema discharge and a positive culturebull Deep space infection - defined as the need for reoperation readmission or percutaneous drainage of a

deep (organ space) infection within 30 days of surgerybull Activity score - defined by a composite score including 4 items using a five point scale lying in bed

getting out of chair or bed walking on level ground and climbing stairsbull Satisfaction score - defined by overall satisfaction of the procedure by the patient measured with a

visual analogue scale

18Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

Teoh 2009 (Continued)

bull Cosmesis score - defined as the score given by the patient on the overall cosmesis of the woundmeasured by the visual analogue scale

bull Quality of life - measured by the gastrointestinal quality of life index (GIQLI) and SF-36 at 2-weeksfollow-up

Starting date October 2009

Contact information Anthony Y Teoh FRCSEd (Gen) 852-26322627 anthonyteohsurgerycuhkeduhk

Notes

19Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

D A T A A N D A N A L Y S E S

This review has no analyses

A P P E N D I C E S

Appendix 1 Search strategy

Medline

1 explode ldquoappendectomyrdquo all subheadings2 explode ldquoappendicitisrdquo all subheadings3 1 OR 24explode ldquolaparoscopyrdquo all subheadings5 keyhole6 4 OR 55 single port6 single incision7 single site8 one port9 incisionless10 scarless11 OR 5 - 1012 AND 3611

Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

1 MeSH descriptor Laparoscopy explode all trees2 (appendectomy) or (appendicectomy)3 (appendicitis)4 1 OR 25 3 AND 4

H I S T O R Y

Protocol first published Issue 3 2011

Review first published Issue 7 2011

20Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd

C O N T R I B U T I O N S O F A U T H O R S

HR - Database search hand search of conference proceedings contacting trial authors and write up of review

IA - Database search hand search of conference proceedings and write up of review

AR - Database search hand search of conference proceedings

D E C L A R A T I O N S O F I N T E R E S T

One of the authors IA is the principle investigator in an ongoing trial

The authors otherwise have no conflicts of interest to declare

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

This review has been authored with no RCTs awaiting the publication of several ongoing

I N D E X T E R M S

Medical Subject Headings (MeSH)

Appendectomy [lowastmethods] Appendicitis [lowastsurgery]

MeSH check words

Humans

21Single incision versus conventional multi-incision appendicectomy for suspected appendicitis (Review)

Copyright copy 2011 The Cochrane Collaboration Published by John Wiley amp Sons Ltd


Recommended