Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

Overview

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.

Full Title of Study: “Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2009

Interventions

  • Procedure: sacral rectopexy with sutures or meshes
  • Procedure: full rectal mobilization from the sacrum without sacral rectopexy

Arms, Groups and Cohorts

  • Active Comparator: Pexy group
    • This group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures
  • Sham Comparator: Non-pexy group
    • These patients will receive full rectal mobilization from the sacrum but without rectopexy

Clinical Trial Outcome Measures

Primary Measures

  • long term recurrence of the rectal prolapse
    • Time Frame: after 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • informed consent – mental ability to understand the procedure – age range 18 to 70 – both sex Exclusion Criteria:

  • patients with recurrent rectal prolapse – previous pelvic or colorectal surgery – previous operation for fecal incontinence – Cancer – chronic intestinal Inflammatory diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Societa Italiana di Chirurgia ColoRettale
  • Provider of Information About this Clinical Study
    • Roberto Bergamaschi MD, PhD, FRCS, State Univeristy of New York , Stony Brook

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