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abstract

32 - RECTOPEXY IN COMBINATION WITH A SACROCOLPOPEXY: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL

032

RECTOPEXY IN COMBINATION WITH ASACROCOLPOPEXY: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL

E. W. HENN1, D. A.BURGER 2;
1Dept. Obstetrics &Gynaecology, Bloemfontein, South Africa, 2Univ. ofPretoria, Pretoria, South Africa.

Introduction: Sacrocolpopexy isthe gold standard procedure for women with advanced pelvic organprolapse (POP) that invariably includes descent of the apicalcompartment1. The addition of a rectopexy can additionallyeliminate a deep cul-de-sac and is associated with improveddefecatory outcomes, especially in women with associated symptomaticrectoceles or rectal intussusception2. Uncertainty existswhether the combination of these procedures provide a superiorclinical result.
Objective: The primary objective was toevaluate the effect of a ventral mesh rectopexy in combination with asacrocolpopexy on the anatomic and symptomatic outcomes aftersurgery.
Methods: This was a randomized controlled trialperformed in an urogynecology referral center in women with advancedmulti-compartment POP scheduled for a sacrocolpopexy. Participantswere randomly assigned to undergo either a sacrocolpopexy alone orcombined with a ventral mesh rectopexy. Exclusion criteria includedan intact uterus and previous mesh-based pelvic reconstructivesurgery. An interim analysis was planned after approximately 50participants. The primary objective was anatomic and functionaloutcome after 12 months. These were respectively evaluated by meansof the pelvic organ prolapse quantification (POP-Q) system andvalidated condition-specific quality of life (QOL) questionnaires.The patients as well as the post-operative assessors were blinded togroup allocation. The clinical data for this study were summarizeddescriptively by randomized group. The statistical analysis wasperformed using SAS® Version 9.4. Inferential statistics were basedon the Kruskal-Wallis test for quantitative data and theFreeman-Halton test for qualitative data.
Results: BetweenJune 2011 and June 2014, seventy-two women were eligible forparticipation. Three declined enrolment and sixty-nine women wereenrolled and randomised to undergo either a rectopexy with asacrocolpopexy (n=36) or a sacrocolpopexy alone (n=33). Thepercentage of participants who followed up at 3, 6 and 12 months were100%, 91.7%, and 91.7% in the rectopexy group and 100%, 93.4% and93.4% in the sacrocolpopexy group. The overall loss to follow-up was7.2%. There were no protocol violations. The mean age was 58.65years, BMI 27.4 kg/m2 and parity 3 for all participants.Half (50.7%) of all participant had previous pelvic reconstructivesurgery. There were no significant baseline differences between therandomized groups. The only significant operative parameter was alonger procedure time in the rectopexy group (122.5 vs 108 minutes,p-value 0.0004). The peri-operative complications were similar incharacter for both groups and the majority were Dindo grades 1-2.Mesh exposure occurred in 6 (16.7%) participants in the rectopexygroup (p-value 0.4764). After 1 year, it was observed that arectopexy did not provide any significant benefits to that ofsacrocolpopexy alone in this population(Table 1-2). Anatomic successrates at 12 months were 87.9% for rectopexy and 93.5% forsacrocolpopexy (p-value 0.6729). The QOL scores improvedsignificantly in both groups (Table 3), but the colorectal-analdistress inventory (CRADI-8) score of the pelvic floor distressinventory (PFDI-20) showed significantly better improvement among thesacrocolpopexy participants (24.52%) than in those randomized torectopexy (49.21%) (P-value ≤ 0.0500).
Conclusions: Therewas no apparent objective or subjective benefit of routinely adding arectopexy to a sacrocolpopexy for women presenting with advancedmulti-compartment POP .
References: 1. Cochrane database2013;4:CD004014 2. World J Gastroent 2016;22:4977-4987

Table1: Chronological POP-Q measurements

Measurement

Rectopexy(N=36)

Sacrocolpopexy(N=33)

P-value

Ba(Pre-op)

-0.19(1.83)

0.32(1.56)

0.2021

Ba(1 year)

-1.70(0.91)

-1.95(0.61)

0.2308

Bp(Pre-op)

0.39(1.69)

0.56(1.59)

0.6393

Bp(1 year)

-2.02(0.83)

-2.27(0.60)

0.2254

C(Pre-op)

-0.82(3.69)

-1.27(3.60)

0.5423

C(1 year)

-8.00(0.94)

-7.66(1.20)

0.3286

GH(Pre-op)

4.72(1.33)

4.32(1.20)

0.2863

GH(1 year)

3.64(0.83)

3.15(2.17)

0.2580


Table2: Functional outcomes

Measure

Rectopexy(N=36)

Sacrocolpopexy(N=33)

P-value

Bulge(Pre-op)

35(97.2)

28(84.8)

0.0968

Bulge(1 year)

3(8.3)

4(12.1)

0.7039

Dyspareunia(Pre-op)

13(36.1)

7(21.2)

0.3714

Dyspareunia(1 year)

6(16.7)

0(0.0)

0.0486*

OAB(Pre-op)

18(50.0)

10(30.3)

0.1409

OAB(1 year)

11(30.6)

5(15.2)

0.1519

SUI(Pre-op)

17(47.2)

13(39.4)

0.6282

SUI(1 year)

2(5.6)

3(9.1)

0.6673

Obstrdefecation (Pre-op)

18(50.0)

14(42.4)

0.6308

Obstrdefecation (1 year)

8(22.2)

5(15.2)

0.5389


Table3: QOL questionnaire results

Questionnaire

Rectopexy(N=36)

Sacrocolpopexy(N=33)

P-value

PFDI-20(Pre-op)

180.58(53.68)

172.12(58.06)

0.6137

PFDI-20(1 year)

38.97(49.21)

19.65(24.52)

0.0425*

PFIQ-7(Pre-op)

173.17(71.78)

159.94(76.80)

0.5088

PFIQ-7(1 year)

29.46(42.35)

15.29(23.92)

0.2440

PISQ-12(Pre-op)

23.73(9.54)

25.75(6.85)

0.6094

PISQ-12(1 year)

31.58(6.88)

34.94(6.52)

0.2878