Laparoscopic Sacropexy Vs Pectopexy for apical prolapse – A single blind randomized controlled trial

Summary

  Background*:* Pelvic organ prolapse (POP) is a common disorder characterized by downward displacement of pelvic organs through vaginal wall. Laparoscopic pectopexy (LP) is a new surgicaltechnique now a days in addition to the conventional laparoscopic sacropexy (LS) in correcting apical prolapse.Sacropexy reduces anatomical recurrence and complication rates, while LP offers shorteroperation times and lower complication rates compared to both native tissue repairs and sacropexy.

Rationale: Intraoperative bleeding is more likely with sacropexy since it requires dissection of the presacral area, especially in elderly and patients using anticoagulants. Since the whole pectopexy procedure takes place in the anterior pelvis, patients with substantial adhesions are spared dissection in the deep pelvis.

Novelty: So far very few randomised controlled trials have been conducted comparing lap sacropexy and lap pectopexy. Most published studies are retrospective studies or prospective cohort studies. Moreover, there are hardly any study comparing long term outcome.

Aim: Comparison of intraoperative parameters and post-operative Surgical outcomes and complications between laparoscopic sacropexy and pectopexy

Objectives:

Primary objective

1.     To compare overall operating time between two methods

2.     To compare post-operative complications using Clavien- Dindo classification and short-term outcome between two methods

3.     To compare quality of life between two methods using validated questionnaires (PISQ-IR) at 7 days after surgery and then every 6 months upto 2 years post-surgery

 Secondary objective

*1.*To compare recurrence rate within two years between two methods

Methods**:** This will be a prospective randomised controlled trial to be conducted at Patna after ethical approval. Total of 50 women fulfilling the inclusion criteria will be screened for the study and their demographic details will be collected. They will be assigned to either laparoscopic sacropexy or pectopexy group in a 1:1 ratio using a random permuted-block algorithm via an interactive Web-based response system. The patient will be blinded to group allocation. A single surgeon will perform all surgeries. Data will be collected using pre-structured data collection proformas. Statistical analysis will be done using appropriate tests of significance. Interim analysis will be done at six months post-surgery.

Expected outcome*.*

For apical prolapse, laparoscopic pectopexy is anticipated to be a safe, practical, and comfortable alternative to traditional sacropexy. It is anticipated that laparoscopic pectopexy will result in a much shorter mesh fixation time, a shorter operating time, and less blood loss than laparoscopic sacropexy .Comparison of outcomes of these two surgical techniques will help in deciding the best feasible surgery with better outcomes and lesser complications.