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