Comparison of functional outcomes with purely laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy in obese women

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ORIGINAL ARTICLE

Comparison of functional outcomes with purely laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy in obese women

Comparaison des résultats fonctionnels de la promontoﬁxation cœlioscopique vs robot-assistée dans une population obèse

M. Joubert

^b

, T. Thubert

^a^,∗,^b

, J.-P. Lefranc

^b

, C. Vaessen

^c

, É. Chartier-Kastler

^c

, X. Defﬁeux

^a

, M. Rouprêt

^c

aServicedegynécologieobstétriqueetmédecinedelareproduction,hôpital Antoine-Béclère,AP—HP,157,ruedelaPorte-de-Trivaux,92140Clamart,France

bServicedechirurgiegynécologie,hôpitalLaPitié-Salpêtrière,AP—HP,83,boulevardde l’Hôpital,75013Paris,France

cAcademicdepartmentofurology,universitéParis6,Pitié-Salpêtrièrehospital,Assistance publique—HôpitauxdeParis,83,boulevarddel’Hôpital,75013Paris,France

Received12July2014;accepted22September2014 Availableonline16October2014

KEYWORDS Genitalprolapse;

Laparoscopy;

Obesity;

Robot-assisted surgery;

Sacrocolpopexy

Summary

Objective.—Tocompare the functional outcomesand complication rates following laparoscopicsacrocolpopexy(LS)withthoseoccurringinrobot-assistedlaparoscopicsacrocolpopexy (RALSCP)inobesewomen.

Patientsandmethods.—Acomparativeretrospectivemulticentrestudywasmade,involving 39obese women(BMI≥30kg/m²)whounderwent LS,and17 obesewomenwho underwent RASCLP.Theoperativeparameters(lengthofoperation,associatedprocedures,complication rateandlengthofhospitalization)andtheobjectiveandsubjectiveresultswereevaluatedat 12monthsfollow-up.

Results.—Themedian(IQR)BMIwas30.5kg/m²(30—32)intheLSgroupvs31.6kg/m²(30—34) intheRALSCPgroup(P=0.402).Theanatomicalresultswerecomparableinbothgroups(LSvs

∗Correspondingauthor.

E-mailaddress:[email protected](T.Thubert).

http://dx.doi.org/10.1016/j.purol.2014.09.045

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RALSCP):post-operativestageofprolapse(POP-Q-ICS):stage0—1:34/39(88%)vs16/17(94.1%), P=0.7;stage2:4/39(10%)vs0/17(0%),P=0.7;stage3—4:1/39(2%)vs1/17(5.9%),P=0.7.

Thecomplicationratewassimilarinbothgroups(LSvsRALSCP):bladderinjury2.5%(1/39)vs 0%(0/17),P=0.6,laparoconversion5.1%(2/39)vs5.9%(1/17),P=0.5.Theoverallreoperation ratewas(LSvsRALSCP):18%(7/39)vs5.9%(1/17),P=0.4.

Conclusion.—Laparoscopic sacrocolpopexy and robot-assisted laparoscopic sacrocolpopexy haveequalresultsinobesewomen.Thecomplicationratesandoutcomesappeartobesimilar inbothgroupsofobesewomen.

Levelofevidence.—3.

MOTSCLÉS Prolapsusgénital; Cœlioscopie; Obésité; Chirurgie robot-assistée; Promontoﬁxation

Résumé

But.—Lebutdenotreétudeétait decomparerla voiecœlioscopiqueetlachirurgierobot- assistéedansunepopulationobèse.

Matériels.—Étuderétrospectivecomparativemulticentriquecomparantdeuxtechniquesde promontoﬁxation:cœlioscopie(groupe1,n=39)vschirurgierobot-assistée(RALSCP)(groupe2, n=17).Les caractéristiquesdes patientes,les paramètresopératoires,complicationsetles résultatsanatomiquesàcourtterme(12mois)ontétéévalués.

Résultats.—L’IMCétaitde30,5kg/m² (30—32)danslegroupe1vs31,6kg/m² (30—34)dans legroupe2(p=0,402).Lesrésultatsanatomiquesàcourttermesontidentiquesdanslesdeux groupes:stade0—1:34/39(88%)vs16/17(94,1%);stade2:4/39(10%)vs0/17(0%);stade 3—4:1/39(2%)vs1/17(0%),p=0,762.Letauxdecomplicationétaitsimilairedanslesdeux groupes(cœlioscopievsRALSCP):plaievésicale2,5%(1/39)vs0%(0/17),p=0,6,laparoconver- sion5,1%(2/39)vs5,9%(1/17),p=0,5.Letauxglobalderé-interventionétaitde(cœlioscopie vsRALSCP):18%(7/39)vs5,9%(1/17),p=0,4.

Conclusion.—Lesrésultatsdelapromontoﬁxationcœlioscopiqueetrobot-assistéesemblent comparableschezlesfemmesobèsesentermesderésultatsanatomiquesetdecomplications.

Niveaudepreuve.—3.

Introduction

Pelvicorganprolapse(POP)isacommoncondition.Bythe age of 80, a woman’s lifetimerisk of undergoinga surgicalprocedure forstress urinaryincontinence(SUI)or POP is estimated to be 11% [1]. A minimally invasive laparo- scopicapproachforthetreatmentofPOP(sacrocolpopexy) has been developed in recent years,andhas been shown tobecomparabletoconventionalsurgeryintermsoffunc- tionaloutcome,whilstdemonstratingalloftheadvantages of laparoscopy [2]. Obesity, which is deﬁned by a body mass index (BMI)≥30kg/m², is endemic in industrialized countries.In2008,theprevalenceofobesityintheUnited Stateswasestimatedtoexceed30%intheadultpopulation, and thecombinedage-adjusted prevalence of overweight andobesityamongwomenwas64.1%(95%CI,61.3%—66.9%) [3].In2010,anestimated17%ofadultswereobeseinthe EuropeanUnion[4].

POP surgery is required for some obese women, and sacrocolpopexyisconsideredtobeoneofthegoldstandards for the surgical treatment of POP. Since 2004, a robot- assistedlaparoscopicapproachtosacrocolpopexy(RALSCP) has been proposed as a viable alternative to the purely laparoscopic technique [5—7]. RALSCP appears to be a practical option for obesewomen, havingsimilarrates of complicationandequivalentoutcomestothosereportedfor

non-obesewomen[8]. Onerecent studycomparedthe LS andRALSCPapproachesinanormal-weightpopulation[9].

However,thereis currently nospeciﬁcdata comparingLS andRALSCPinobesewomen.Theaimofourstudywasthus tocomparetheoperativeandfunctionaloutcomesofLSand RALSCPinwomenwithaBMIgreaterthan30kg/m².

Methods Population

Inthisstudy,weretrospectivelyreviewedalloftheprospec- tive data collected from obese female patients who had undergone RALSCP or LS between January 2008 and Jan- uary2013, andwhohadattendedanyone ofﬁvetertiary care centres in France. The following parameters were extractedfromtheircharts:ageatthetimeofsurgery,BMI, menopausestatus,initialstageofgenitalprolapse(accord- ingtotheBadenandWalkerclassiﬁcation)[10],pastmedical history,obstetricandsurgicalhistories,pastprolapsetreat- ment(s),date ofthe sacrocolpopexyprocedure, operative andperioperativedata,complications,anatomicalresults, andfunctionalresults.

Eachpatientunderwentapre-operativework-up,includ- ing urine analysis, a Pap smear, pelvic ultrasonography,

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andurodynamicexploration.Objectiveassessment ofPOP was carried out using a split speculum during a Valsalva manoeuver in the gynaecological position, following the POP ICS stage of POP [10]. Each surgeon performed a prolapse-reduction manoeuver using sponge-holding for- ceps in order to reveal the possible presence of masked urinary-stressincontinence.

Operativeandperioperativedataincluded:concomitant surgicalprocedure (subtotalhysterectomyor mid-urethral sling);conversiontoalaparotomy oravaginalprocedure;

length of the operation; blood loss; type of anaesthe- sia (according to the WHO classiﬁcation); occurrence of complications;analgesicrequirements;andlengthofhospi- talstay.TheEthicalReviewCommittee(CEROG)examined thepresentstudyandfoundthatitcompliedwiththegen- erallyacceptedscientiﬁcprinciplesandethicalstandardsof medicalresearch,andwasinagreementwiththelawsand regulationsofthecountryinwhichtheresearchexperiment wascarried out(submission number CEROG-GYN-2011-08- 01;CNGOF,Paris).

Surgical procedure

Alaparoscopic sacrocolpopexy wasperformed by a senior surgeon on all patients, in accordance with the method statement provided hereafter. A pneumoperitoneum was createdandfourlaparoscopicportswereplaced:one10mm umbilical port, one 10mm midline suprapubic port, and two5mmlateralports.Followingidentiﬁcationoftheright ureter,theleftiliacveinandtheiliac-vessel junction,the peritoneumabovethesacralpromontorywasincisedmedi- allytotherightureterandlaterallytothesigmoidcolon.

Eitheraprostheticmacroporous monoﬁlamentpolypropyl- enemesh, or apolyester mesh,were usedin 2/39(5.2%) and37/39(94.8%)patients,respectively. The bladderwas dissectedfromtheupperhalfoftheanteriorvaginalwall.

Ameshwassuturedtotheanteriorwallofthevaginausing a non-absorbablesuture. A posterior mesh was placed in 3/39(7.6%)of patients,asaconsequenceofthepresence of a posterior compartment vault (elythrocele, rectocele or enterocele). Forthe posterior mesh placement,a rec- tovaginaldissectionwasperformeddowntothelevelofthe levatorani muscles, and a mesh was placed and sutured tothelevator animuscles usinga non-absorbablesuture, alongthefulllengthoftheposteriorvaginalwall.Theupper extremity of the anterior mesh was suturedto the ante- riorvertebralligament in front of the sacral promontory, usinganon-absorbablesuture.Completeperitonisationof themesheswasachievedbyjoiningtheedgesoftheperi- toneumwithanabsorbablesuture.

ConcerningtheRALSCP,allprocedureswerecarriedout withathree-armdaVinci^®surgicalsystem,usingthetrans- peritonealfour-porttechnique,asdescribedpreviously[9].

TwosurgeonsperformedRALSCPonallofthewomen.These surgeonshadalreadycompletedtheirtrainingandcarried outsacrocolpopexybyLSorRALSCPwiththesameoperative skill.Followingidentiﬁcationoftherightureter,theleftiliac vein,andtheiliac-vesseljunction,theperitoneumoverthe sacralpromontorywasincisedmediallytotherightureter andlaterallytothesigmoidcolon.Fortheplacementofthe posteriormesh,therectovaginawasdissecteddowntothe levelofthelevatoranimuscles,andameshwasplacedand

suturedwithnon-absorbablesuturesalongthefulllengthof theposteriorvaginalwallandintothelevatoranimuscles.

Theupperextremityoftheanteriormeshwassuturedwith anon-absorbablesuturetotheanteriorvertebralligament atthelevelofthesacralpromontory.Completeperitoniza- tionofthemesheswasachievedbyattachingtheedgesof theperitoneumusinganabsorbablesuture.Forbothsurgi- calprocedures,thesurgicaltimewasdeﬁnedastheduration oftheprocedure(excludingpreparationanddockingofthe robotusedfortheRALSCP),plusthetimerequiredforinser- tionoftheports.

Complications

Concerning the reporting of morbidity and surgical complications, the authors followed the 10 criteria proposed by Martin et al. in 2002, as well as those established bythe InternationalUrogynecologicalAssocia- tion/Internationalcontinencesociety(IUGA/ICS),asstated intheEuropeanGuidelines[11,12].

Follow-up

Post-operativefollow-upvisitswerescheduledat6and12 months,andthen everyyear. Duringthesevisits, thePOP wasassessedusingthePOPICSquantiﬁcation.Thesurgery wasconsideredtohavebeensuccessfulifthepatientwas symptomaticallysatisﬁedandthePOPscorewasbelowstage 2forallcompartments.

Statistical analysis

The data was statistically analysed using the R statisti- calsoftware(BellLaboratories,LucentTechnologies,Paris, France). The descriptive statistics are given in the form of median values and IQRs (interquartile range). The Mann—Whitney U-test was used to compare continuous variables,andFisher’sexacttestwasusedtocomparecat- egoricalvariables.AP-valueof<0.05wasconsideredtobe statisticallysigniﬁcant.

Results Population

Thirty-nine obese patients underwent a laparoscopic sacrocolpopexy (group 1), and 17 patients underwent a robot-assisted laparoscopicsacrocolpopexy (group 2).The median (IQR) BMI was 30.5kg/m² (30—32) in group 1 vs 31.6kg/m² (30—34) in group 2 (P=0.4). The median age was 54 years (48—58) in group 1 vs 63 (56—69) in group 2 (P=0.002).There wasnostatistical differencebetween thetwogroupsforanyoftheotherpatientcharacteristics.

TheseresultsaresummarizedinTable1.

Surgery

The surgical data are shown in Table 2. No signiﬁcant differencewasobservedbetweenthegroups,withrespect totheneedforaconcomitantprocedure,suchasasubtotal hysterectomy or a mid-urethral sling. The perioperative

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Table1 Patient’scharacteristics.

Laparoscopy RASCLP P

n 39 17

BMI(kg/m²)median(IQR) [Extrem]

30.48(30—32) [30—42]

31.6(30—34) [30—36]

0.402^a

Age(years)median(IQR) 54(48—58) 63(56—69) 0.002^a

Parity(n)median(IQR) 2(2.0—3.5) 3(1—3) 0.220^a

Post-menopausalstatusn(%) 21/39(54%) 15/17(83.3%) 0.030^b

Pessaryusen(%) 1/37(2.7%) 1/17(5.6%) 0.804^b

Pelvicﬂoorrehabilitationn(%) 5/37(13.5%) 1/17(5.6%) 0.716^b

Tobaccousen(%) 6/39(15%) 1/17(5.6%) 0.582^b

PreviousC-sectionn(%) 4/39(10%) 3/17(16.7%) 0.741^b

Previoushysterectomyn(%) 2/39(5%) 4/17(22.2%) 0.114^b

PreviousPOPsurgeryn(%) 9/39(23%) 2/17(11.2%) 0.539^b

POPstage(ICSPOP-Q) Stage0—1

Stage2 Stage3—4

0/39(0%) 3/39(8%) 36/39(92%)

0/17(0%) 2/17(11.2%) 15/17(88.8%)

0.985^b

Bp(ICSPOP-Q) Stage0—1 Stage2 Stage3—4

14/39(36%) 15/39(38%) 10/39(26%)

5/17(29.4%) 6/17(35.3%) 6/17(29.4%)

0.870^b 0.940^b 0.679^b

SUIpatentn(%) 5/39(13%) 2/17(11.2%) 0.741^b

SUImaskedn(%) 13/34^c(38%) 10/15^c (66.7%) 0.894^b

BMI:bodymassindex;ICS:internationalcontinencesociety;IQR:interquartilerange;POP:pelvicorganprolapse;POP-Q:pelvicorgan prolapsequantiﬁcationgradingsystem;SUI:stressurinaryincontinence.

a Welchtwosamplet-test(Studentt-test).

b Pearson’sChi²testwithYates’continuitycorrection(Chi²test).

c Patientswithoutpatentstressincontinence.

complicationratewassimilarinbothgroups.Inparticular, for theLS group andRALSCPgroups respectively: bladder injury2.5%(1/39)vs0% (0/17),P=0.6;andlaparoconver- sion for perioperative complications 5.1% (2/39) vs 5.9%

(1/17), P=0.6. Conversion to abdominal laparotomy was

requiredforonepatient(5.9%)ingroup2,asaconsequence of pneumoperitoneum intolerance. In the LS group, a conversion to abdominal laparotomy was required for 2 patients(5.1%),asaresultofvesselinjuries.Bothofthese casesresultedfromdifﬁcultaccesstothepromontory,due

Table2 Operativedata.

n 39 17

Concomitantsubtotalhysterectomy n(%)

13/37^a(35%) 2/13^a(15.4%) 0.324^b

Concomitantmid-urethralslingn (%)

13/39(33%) 11/17(64.7%) 0.059^b

Meshlocationn(%) Anteriormeshonly Posteriormeshonly Bothanteriorandposterior meshes

3/39(8%) 2/39(5%) 34/39(87%)

0/17(0%) 0/17(0%) 17/17(0%)

<0.005^b

Operativeduration(min) Median(IQR)

190(160—237) 220(170—320) 0.253^c

Hospitallengthofstay(days) median(IQR)

4(3.0—4.0) 4(4—5) 0.989^c

n:number;IQR:interquartilerange.

a Patientswithoutprevioushysterectomy.

b Pearson’sChi²testwithYates’continuitycorrection(Chi²test).

c WelchtwoSamplet-test(Studentt-test)

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Table3 Complicationsandoutcomes.

n 39 17

Bladderinjuryn(%) 1/39(2.5%) 1(5.9%) 0.866^a

Rectalinjuryn(%) 0 0 NS

Laparoconversionn(%) 2/39(5.1%) 1(5.9%) 0.596^a

Woundinfectionn(%) 1 0 NS

Douglaspouchhaematoma 1 0 NS

Bowelocclusion 0 0 NS

Pelvicabscess 1 0 NS

Reoperationforimmediate complications(C1)

2/39(5.1%) 0(0%) 0.879^a

Reoperationforurinary incontinence(C2)n(%)

2/39(5.1%) 0(0%) 0.879^a

Reoperationformeshexposure (C3)n(%)

2/39(5%)^b 0(0%) 0.879^a

Reoperationforrecurrentprolapse (C4)n(%)

1/39(2.5%) 1(5.9%) 0.866^a

Globalreoperationrate (C1+C2+C3+C4)n(%)

7/39(18%) 1(5.9%) 0.44^a

Post-operativePOPstage(ICS POP-Q)n(%)

Stage0—1 Stage2 Stage3—4

34/39(88%) 4/39(10%) 1/39(2%)

16(94.1%) 0(0%) 1(5.9%)

0.762^a

Post-operativedenovofunctional disorders

Constipation

Strainingtodefecate Strainingtovoid Dyspareunia

3/39(7.6%) 1/39(2.5%) 2/39(5%) 0/39(0%)

0(0%) 0(0%) 1(5.9%) 0(0%)

0.596â 0.666â 0.596â NS

ICS:internationalcontinencesociety;n:number;POP-Q:pelvicorganprolapsequantiﬁcationgradingsystem.

aPearson’sChi-squaredtestwithYates’continuitycorrection(Chi²test).

b Allthepatienthavebeenreoperatedbyvaginalapproachwithpartialresectionofthemeshandvaginalsuture.Patientsfollowed withaPOP-Qexam(3lossofsight).

tothepresenceofexcessivefat.Inonecase,apre-sacral vesselinjury occurred,and inthe second casea leftiliac veininjuryoccurred.Asaconsequenceofdifﬁcultiesexpe- riencedinachievingselectivehaemostasisofthevessel,the surgeonwasforcedtoconverttolaparotomy.Theoperative time was similar in both groups, with a mean value of 220minutes (170—320) vs 190minutes (160—237) for the RALSCPandLSgroups,respectively(P=0.253)(Table3).

Outcomes and complications

Themedianfollow-upperiodwas14.9months(IQR8—25)in theLSgroupand12months(IQR:7—15)intheRALSCPgroup (P=0.42).The overallanatomicrepairrates were98%and 94.1%fortheLSandRALSCPgroups,respectively(P=0.7).

Duringthefollow-up,agynaecologicalexaminationrevealed thatprolapse of theposterior compartment hadrecurred in onepatient in theRALSCP groupafter 12 months,and prolapseoftheanteriorcompartmenthadrecurredinone patientin the LS group.Bothof these women underwent a subsequent procedure via the vaginal route. In the LS group,3(7.6%) post-operativecomplicationsoccurred: an

infected injury(n=1),aDouglas pouchhaematoma(n=1) and a pelvic abscess (n=1). In the RALSCP group, there werenopost-operativecomplications(P=0.6).Theoverall reoperationratewassimilarin bothgroups: 18%(7/39) vs 5.9%(1/17),P=0.4.Allofthepost-operativecomplications arelistedinTable4,inaccordancewiththeICS/IUGAclas- siﬁcation.

Discussion

Theaimofthisstudywastoestablishacomparisonbetween the LS and RALSCP procedures in obese women. It was observedthattheoverallanatomicalsuccessratewas98%

fortheLSgroup,and94.1%fortheRALSCPgroup(P=0.7).

Furthermore,nosigniﬁcantdifferenceincomplicationrate was observed between the two groups, for which similar operativetimeswererequired.

Inthepast,abdominalsacrocolpopexy(ASC)wasconsid- eredtobethegoldstandardtreatmentforgenitalprolapse [13]. The functional outcome, operative characteristics and complications associatedwith thissurgical procedure

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Table4 OperativecomplicationsusingIUGA/ICSclassiﬁcation.

T1complications 1(4A/T1/S5)

2(7A/T1/S5)

1(7B/T1/S5) 0.747^a

T2complications 1(7A/T2/S2)

1(1D/T2/S2) 1(6D/T2/S3)

0 0.596^a

T3complications 1(2B/T3/S1) 0 0.664^a

T4complications 1(2B/T4/S1) 1(1B/T4/S2) 0.866^a

a Pearson’sChi²testwithYates’continuitycorrection(Chi²test).

havebeenevaluatedfornormal-weightandobesewomen.

Bradley et al. [14] reportedthat perioperative and post- operativecomplications,aswellaspost-operativeprolapse quantification were similar in obese and healthy-weight women. The differences between obese and non-obese women were related to the operative times only, these being significantly longer in the case of obese women (189minasopposedto169min,P=0.02)[14].The laparoscopic approach was developed over the past decade, in response to the ideal requirement for POP repair to be as little invasive as possible, with good anatomical and preservefunctions.Onlyoneprevious studyhasevaluated the feasibility of this approach in obese women [15]. In the latter study, similarly to the results of Bradley [14], perioperative and post-operative complications, as well aspost-operativeprolapsequantifications, weresimilarin obese and healthy-weight women. Contrary to Bradley’s findings [14], the operating times were similar in both populations,with190min in obesewomen versus 180min innon-obesewomen,respectively(P=0.12).The inexperi- encedlaparoscopic surgeonfound thatthisprocedure had some limitations, such as a reduced freedom of move- ment,two-dimensionalvision,andalongeroperativetime asa consequence of the need for significant training. All of these drawbacks demotivated a large number of sur- geons,whopreferredtoavoidthe laparoscopicapproach.

Robotic-assistedsurgerywasthusdevelopedtosimplifythis technique,throughtheadditionofthree-dimensionalvision and 7 degrees of freedom. This simpliﬁed the complex laparoscopictaskssuchassuturingandknot-tying,needed in the treatment of genital prolapse. One recent study evaluated the functional outcomes after robot-assisted laparoscopicsacrocolpopexyinwomenwithaBMIaboveand below30kg/m²[8].Theoverallanatomicrepairrateswere 94.1%and97.4%fortheobeseandnon-obesegroups,respectively (P=0.95). No signiﬁcant difference was observed betweenthetwogroupsintermsofcomplicationrates,with an overall reoperationrate(includingsurgeryfor denovo urinary-stressincontinence)of5.9%intheobesegroup,versus 11.5% in the non-obesegroup (P=0.8). The operating timewas the same in both groups: 220 vs 200min in the obeseandnon-obesegroups,respectively(P=0.232).

One recentrandomizedtrial comparing LS andRALSCP in78normal-weightwomenfoundthatthecostsofrobotic sacrocolpopexywerehigherthanthoseoftheconventional laparoscopicprocedure, whereastheshort-termoutcomes

(exceptforpainat1week,whichwashigherinRALSCPthan inLS)andcomplicationsweresimilar[16].Onepreviousran- domizedtrial found that patients whounderwent RALSCP hadsignificantlygreaterpainduringrestandactivity,from the 3rd to the 5th week following surgery, and required a more prolonged use of non-steroidal anti-inflammatory drugs[17].Concerningtheoperatingtime(fromincisionto closure),bothtrialsfoundthatthetotaloperativetimewas significantlylongerintheroboticgroupthaninthelaparo- scopicgroup. Inaddition,Angeretal.confirmed thatthe timespentinthe operatingroomwasgreater inthe case of robot-assistedsurgery (202.8minutes vs 178.4minutes, P=.030)[16].Inarecentreviewoftheliteraturemadeby Leeetal.[18],theoverallmeanoperatingtimewas124min (range:55—185)for LS, and202min (range:161—288) for RALSCP. Our study focused on obese people. Contrary to thecaseofnormal-weightpopulations,wedidnotobserve anysignificantdifferencesintermsofoperatingtime,even though theRALSCPdoes appeartobe slightly longer,i.e.

220minutesvs190minutes(P=0.25).Inaddition,therate ofconcomitantprocedureswassimilarinbothgroups26/39 vs13/17(P=0.68).

In the current study, independently of the surgical approach,wedidnotencounterahighrateof(peri-orpost- operative) complications. The overall reintervention rate (includingdenovoSUIsurgery)wassimilarinbothgroups:

18%(7/39)vs5.9%(1/17),P=0.4.Thecurrentopinionisthat obesepatientsareatahigherriskofmorbidity.Asmallnum- berofpreviousstudieshaveshownthatabdominalsurgery for a gynaecologically benign condition (other than POP) isassociated witha greater incidenceof wound infection in obesewomen, than in non-obesewomen [19,20]. Only threeprevious retrospective studies have focused on the impactofBMIonthesurgicaloutcomesofprolapsesurgery.

Chenet al.[21], whofocused onvaginal surgeryfor prolapse or urinary incontinence, did not ﬁnd any statistical differencein theproportion of subjectshaving at least 1 perioperativecomplication(20%intheobesegroupvs15%in thenon-obesegroup,P=NS).However,obesewomenwere morelikely tohave an operative site infection (AOR=5.5 [95%CI, 1.7—24.7; P=0.01]) andmorbidly obese patients (BMI≥35kg/m²)weremorelikelytohaveabladderinjury (AOR=6.9 [95% CI, 1.7—24.0; P=0.003]). Namet al. [22]

foundthatvaginalsurgeryforPOPinobesewomenisassoci- atedwithalowermorbidityratethanabdominalsurgery,in termsofbloodtransfusionsorurinaryretention.Aracoetal.

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[23],whostudiedtheinﬂuenceofbodymassindexonthe riskofvaginalmeshexposurefollowingmeshrepairofpelvic prolapses, found that a BMI≥30kg/m² conferred a 10.1 foldincreasein therisk ofdeveloping erosion(22months follow-up (range12—48 months)). Clark et al. [24] found nocorrelation betweenBMIandPOP recurrenceratesfol- lowingsurgeryforPOPand/orurinaryincontinence.These investigatorsfollowed376patientsforaperiodof5years, duringwhichonly36patients(9.5%)underwentatotalof40 reoperationsforsurgicalfailure.Loetal.[25]comparedthe surgicaloutcomesofanteriortrans-obturatormeshandvagi- nal sacrospinousligament ﬁxation for severe pelvic organ prolapse,asa functionof the patient’sBMI, withamean follow-upof 35±18.9months. Therewerenodifferences betweennormal-weightandobesewomen,withrespectto perioperativecomplicationsandvaginalmeshexposurerate (4.1%). In the present study, the overall reoperation and vaginalerosionratesweresimilarinthenormal-weightpopulation.

Thereis onlyonestudy(with asmallsamplesize)that has focused on the impactof BMI on the functional outcome ofgenital prolapsesurgery. The major limitationof all of these studies is their short follow-up period, ran- gingfrom6monthsto2years.Twoyearsafterabdominal sacrocolpopexy,Bradleyetal.[14]foundsimilaroutcomes in obeseand healthy-weightgroups. Symptom resolution, measured according to the UDI, POPDI, and CRADI score changes,as well assatisfactionwith surgery, didnot dif- ferbetween the groups. The POP-Q examination wasthe same in both groups, apart from the fact that a smaller maximum posterior vaginal descent (point Bp, cm) (—3.0 (—3.0to —2.0))was observed in the obesegroup than in thenormal-weightgroups(—2.0(—3.0to—1.0))(P=0.003).

Mcdermottetal.[26]comparedabdominalsacrocolpopexy andLSinobesewomenwithafollow-upof6to12months.

They found a similar overall satisfaction rate (86/100 in theASC vs81/100 in theLS, P=0.8) and similarsuccess- fulanatomicalresults(88/100 intheASCvs88/100inthe LS,P=1).Followingalaparoscopicsacrocolpopexy,Thubert etal. [15] found a similarrate of short-term satisfaction (6 months) in the obese and non-obese populations. The patients’globalrateofsatisfactionwithLSwas74.5%inthe obesegroup and 67.9% in the non-obese group (P=0.09).

The short-termanatomicalresults assessedby POP-Q—ICS for post-operative functional disorders described by the obeseandnon-obesegroups(denovoconstipation,denovo anorectaldysfunction,voidingdysfunction,anddenovodys- pareunia)weresimilar.Loetal.[25]comparedtheoutcomes ofvaginalprolapsesurgeryasa functionofBMI,revealing an objectivecurerate of90.6% in obesepatients, witha 35±18.9monthfollow-up.Theonlydifferencewithrespect tothenormal-weightpopulationwasrelatedtothePOPDI-6 (P<0.037) and thePISQ-12 (P<0.005),with lessimprove- mentintheobesethaninthenon-obesegroup.

One of the limitations of the current series is itsret- rospective design and the small size of the population.

Nevertheless,this isthe ﬁrststudy tohave comparedthe laparoscopic and robot-assistedapproaches for the treat- mentofgenitalprolapseinobesewomen.Anotherlimitation ofourstudy istheshort-termfollow-upofthesepatients.

Anextendedfollow-upperiodwouldbeneeded toconﬁrm theseﬁndingsoverthelongerterm,eventhoughobesityis

notconsideredtobeafactoraffecting recurrenceingen- ital prolapse. Arandomizedprospective study,madewith a larger population, would beof considerable interest in comparingtheperformanceachievedusingthevaginalroute withthatoftherobot-assistedandlaparoscopicapproaches, forthetreatmentofprolapseinobesewomen.

Conclusion

RALSCPcanbea viablealternative tolaparoscopy for the treatment of prolapse in obese women. It is shown that an inexperienced laparoscopic surgeon can achieve the sameanatomicalresultsandthesamerateofperioperative complicationsasanexperiencedRALSCPsurgeon.Neverthe- less, when performed by a trained urogynecological staff surgeon,experiencedintheuseofbothRALSCPandLS,LS shouldbepreferredforreasonsofcost.

Disclosure of interest

Theauthorsdeclarethattheyhavenoconﬂictsofinterest concerningthisarticle.

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