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Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study

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Summary

Background

Laparoscopic ventral mesh rectopexy for rectal prolapse has been widely used over the past decade to reduce postoperative functional bowel disorders. We aimed to compare changes in functional outcome 12 months after laparoscopic ventral mesh rectopexy versus laparoscopic posterior sutured rectopexy in patients with rectal prolapse.

Methods

In this double-blind, randomised trial, consecutive patients aged 18 years or older at a single centre in Denmark with full-thickness rectal prolapse were randomly assigned (1:1) to either laparoscopic ventral mesh rectopexy or laparoscopic posterior sutured rectopexy by drawing numbers from opaque envelopes, in blocks of four for patients with or without preoperative constipation. Functional assessment was done preoperatively and 12 months postoperatively. The primary outcome was preoperative-to-postoperative change in obstructed defecation syndrome (ODS) score. Patients and those assessing the outcomes were masked to the procedure. The primary analysis was done in the per-protocol population. Safety outcomes were assessed in the entire cohort. The trial is registered with ClinicalTrials.gov, number NCT00946205.

Findings

From Nov 1, 2006, to Jan 31, 2014, 75 consecutive patients were assigned to laparoscopic posterior sutured rectopexy (n=37) or laparoscopic ventral mesh rectopexy (n=38). Eight patients withdrew consent to follow-up, leaving 34 patients in the posterior sutured rectopexy group and 33 in the ventral mesh rectopexy groups for the primary analysis. The preoperative-to-postoperative reduction in ODS score was 1·97 (95% CI 0·01 to 3·93) in patients who received ventral mesh rectopexy and 2·18 (−0·14 to 4·49) in those who received posterior sutured rectopexy (difference −0·21 [–3·19 to 2·78]; p=0·890). Postoperative surgical complications of Clavien-Dindo grade II or worse were reported in one (3%) of 38 patients in the ventral mesh rectopexy group (ureteral injury resulting in urine leakage, and a psoas abscess) and one (3%) of 37 patients in the posterior sutured rectopexy group (haematoma and pelvic abscess). Two (5%) patients in the posterior sutured rectopexy group developed recurrence within 12 months compared with none in the ventral mesh rectopexy group (p=0·305).

Interpretation

Functional outcome measured by preoperative-to-postoperative change in ODS score was not significantly superior in patients who underwent ventral mesh rectopexy compared with those who had posterior sutured rectopexy. Additional, large, randomised, multicentre studies with long-term outcomes are warranted.

Funding

None.

Introduction

Full-thickness rectal prolapse is a disabling condition with an annual incidence of 2·5 per 100 000 people.1 Over the past century, more than 100 different procedures have been developed for surgical treatment of external rectal prolapse, but universal consensus on the optimal surgical approach has not yet been reached. Perineal procedures are usually reserved for patients with substantial comorbidity who are unfit for general anaesthesia and abdominal operation. Abdominal procedures are increasingly laparoscopic and might lead to better functional outcome and lower recurrence than perinanal procedures.2

Laparoscopic posterior sutured rectopexy has been widely used because it is a straightforward, easy procedure. More recently, laparoscopic ventral mesh rectopexy has gained widespread popularity. The two techniques differ in the method of rectal mobilisation and fixation. In posterior sutured rectopexy, the posterior-lateral aspect of the rectum is fully mobilised and sutured to the presacral fascia. In ventral mesh rectopexy, the rectum is mobilised anteriorly and the anterior wall of the rectum is fixed to the sacral promontory with mesh. Because posterior dissection does not occur in ventral mesh rectopexy, autonomic nerve damage is less of a risk, which might lead to better functional outcomes.3 However, the two techniques have never been compared in a randomised study.

The aim of this trial was to compare the preoperative-to-postoperative change in obstructed defecation 1 year after laparoscopic ventral mesh rectopexy with that of laparoscopic posterior sutured rectopexy in patients presenting with overt rectal prolapse.

Research in context

Evidence before this study

Full-thickness rectal prolapse is a debilitating condition. Throughout the past few decades a large number of different operations have been developed to treat the condition; however, no consensus has been reached regarding the best operation. We did a systematic search of PubMed and the Cochrane Library until Dec 31, 2015, using the terms “rectal prolapse”, “VMR”, “ventral mesh rectopexy”, “rectopexy”, and “functional results” with no data or language restrictions. We identified three Cochrane reviews. A review update from 2015 of two previously published Cochrane reviews from 1999 and 2008 included 15 randomised controlled trials involving 1007 participants. Different approaches and techniques were compared, but the heterogeneity of the different trial objectives, interventions, and outcomes and the small sample sizes made it difficult to draw any solid conclusions to guide practice. A systematic review of laparoscopic ventral rectopexy from 2014 reported on 23 studies including 1460 patients. Of these, only seven reported on the outcome for full-thickness rectal prolapse, whereas the remainder reported on obstructed defecation or a mixture of the two conditions. The literature is generally very heterogeneous and few studies focus on functional results.

Added value of this study

Ventral mesh rectopexy has, especially in Europe, emerged as the preferred treatment for full-thickness rectal prolapse to obtain the best postoperative functional results. Our study is the only randomised trial to compare preoperative-to-postoperative changes in functional outcome between laparoscopic ventral mesh rectopexy and posterior sutured rectopexy. The primary endpoint was change in obstructed defecation syndrome score at 12 months, which we believe is the most important outcome measure for this treatment. This study was not able to show that ventral mesh rectopexy is superior to posterior sutured rectopexy in terms of functional outcome.

Implications of all the available evidence

The literature about the optimal treatment of full-thickness rectal prolapse has a shortage of well-designed studies with a sufficient number of patients and long-term follow-up. This trial questions the general opinion that ventral mesh rectopexy is superior to posterior sutured rectopexy in terms of functional outcome. However, additional, large, randomised, multicentre studies with long-term outcomes are warranted.

Section snippets

Study design and patients

All patients referred to the Department of Surgery, Aarhus University Hospital, Denmark, with a primary full-thickness rectal prolapse suitable for an abdominal procedure were eligible for this double-blind, randomised trial. Exclusion criteria were age younger than 18 years; pregnancy or breast-feeding; dementia or any psychiatric disease with inability to give informed consent; recurrent rectal prolapse; and inability to speak or read Danish. The diagnosis of rectal prolapse was based on

Results

From Nov 1, 2006, to Jan 31, 2014, 75 consecutive patients with rectal prolapse for whom the department otherwise would offer abdominal rectopexy were, after informed, written consent, randomly assigned to either laparoscopic posterior sutured rectopexy (37 patients) or laparoscopic ventral mesh rectopexy (38 patients). 34 patients in the laparoscopic posterior sutured rectopexy group and 33 patients in the laparoscopic ventral mesh rectopexy group completed the ODS score assessment at 12-month

Discussion

This study is, to our knowledge, the first randomised, controlled, double-blind trial comparing preoperative-to-postoperative changes in functional outcome between two laparoscopic procedures for full-thickness rectal prolapse. Our results showed that functional outcome after ventral mesh rectopexy was similar to that after posterior sutured rectopexy, measured by changes in obstructed defecation score, constipation score, and incontinence score measured before surgery and 12 months after.

The

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