Clinical Trial: Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial

Brief Summary:

No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full‐thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.

Method: This is a multicenter randomized non‐inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre‐RCT meta‐analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5‐year cumulative recurrence rate. Recurrence‐free curves will be generated and compared using the Kaplan‐Meier method and log‐rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.

Detailed Summary:
Sponsor: Societa Italiana di Chirurgia ColoRettale

Current Primary Outcome: long term recurrence of the rectal prolapse [ Time Frame: after 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Societa Italiana di Chirurgia ColoRettale

Dates:
Date Received: November 25, 2009
Date Started: January 2003
Date Completion:
Last Updated: December 1, 2009
Last Verified: December 2009