Clinical Trial: Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal

Brief Summary: Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.

Detailed Summary:
Sponsor: Renmin Hospital of Wuhan University

Current Primary Outcome: Changes in the ODS score (ODS-S) and Patient Assessment of Constipation- Quality of Life score (PAC-QoL) [ Time Frame: Baseline, 1 month after surgery ]

The primary outcome measure will be the percent change from baseline in the sum of ODS-S and PAC-QoL at 1 month after the surgery. This measures the symptomatic improvement in ODS.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in the ODS score (ODS-S) [ Time Frame: Baseline, 1, 3, 6 and 12 months after surgery ]
    This is a measure of efficacy.
  • Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL) [ Time Frame: Baseline, 1, 3, 6 and 12 months after surgery ]
    This is a measure of efficacy.
  • Changes in Health-Related Quality of Life [ Time Frame: Baseline, 1, 3, 6 and 12 months after surgery ]
    SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.
  • Changes in Cleveland Clinic Fecal Incontinence Score (CCFI) [ Time Frame: Baseline, 1, 3, 6 and 12 months after surgery ]
    This is a measure of efficacy.
  • Changes in Fecal Incontinence Quality of Life Scale (FIQoL) [ Time Frame: Baseline, 1, 3, 6 and 12 months after surgery ]
    This is a measure of efficacy.
  • Radiological outcome as assessed by defecography [ Time Frame: Baseline, 6 and 12 months after surgery ]
    This is a measure of efficacy.


Original Secondary Outcome: Same as current

Information By: Renmin Hospital of Wuhan University

Dates:
Date Received: February 14, 2017
Date Started: April 26, 2017
Date Completion: April 2020
Last Updated: May 1, 2017
Last Verified: May 2017