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A subanalysis of a randomized controlled trial:Abdominal vs laparoscopic sacrocolpopexy

Abstract: PD17-01
Sources of Funding: NONE

Introduction

This is a sub analysis of our previous RCT that compared abdominal (AS) versus laparoscopic Sacrocolpopexy (LS). In present study enrolled patients were divided in 3 subgroups: Sacrocolpopexy (SC), Hysterectomy (HY)and SC and Hysterosacropexy (HS).The aim of this study is to compare AS vs LS in each of the subgroups

Methods

Patients with symptomatic pelvic organ prolapse (POP)> stage II were assigned to one of the two groups (LS or AS). Surgery was performed by 2 senior surgeons skilled in both procedures. The analysis was performed in the 3 different surgical subgroups: SC for vaginal vault prolapse (group 1), HY and SC for advanced utero-vaginal prolapse (group 2) and HS when uterus was preserved (group 3).The primary outcome included the anatomic results (POP-Q system). Cure was defined as POP stage? I, for the apex or point C/D ? -5, for total vaginal length at least 7 cm. Secondary outcomes included complication rate, operating time, intra-operative blood loss, hospital-stay length, functional results and satisfaction (PGI-I scores). Statistical analysis : The Mann-Whitney, McNemar, X2 test.

Results

121 consecutive women were included in the RCT (60 AS, 61 LS). In this sub-analysis we compared 3 surgical subgroups: Group 1 (28): 14 AS, 14 LS; Group 2 (45): 24 AS, 21 LS; Group 3 (47): 22 AS, 25 LS. The groups were comparable for demographic and clinical characteristics. Mean follow-up was of 45.4 months. There was a statistical functional and anatomical improvement in all subgroups in both groups.The recurrences (stage I or II) in anterior compartment were significantly more common in the LS group (in particular in group3) (p=0.015), while in posterior compartment was more frequently but not significantly present in the AS group (p=0.736). Intra-operative median blood loss(p<0.001), hospital stay (p<0.0001) and median operating time (group 3 p<0.0001 and group 2 p?0.022) were lower in LS in all the 3 subgroups. There were no significant differences in the grade of complications among surgical subgroups in both groups (AS p=0.845, LS p=0.250). The majority of complications were observed in group 2 (16/24 in AS and 9/21 in LS, p=0.193). There were 3 mesh exposure in LS ( 2 group 2 and 1 group 1) and 1 in AS (group 2).

Conclusions

LS can be considered an excellent option in patients with severe urogenital prolapse,with functional and anatomical outcomes and patient's satisfaction as good as AS in all the subgroups. The recurrence rate of anterior compartment is higher in LS especially when uterus is preserved. LS had best intraoperative and peri operative results compared to AS group.

Funding

NONE

Authors
Ester Illiano
Luigi Mearini
Alessandro Zucchi
Manuel Di Biase
Elisabetta Costantini
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