Pexy Versus Non-pexy for Full Thickness Rectal Prolapse (Bergamaschi)

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Prolapse
• Intervention / Treatment: Procedure: sacral rectopexy with sutures or meshes; Procedure: full rectal mobilization from the sacrum without sacral rectopexy

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11794-3368
      • Stony Brook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pexy group; This group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures	Procedure: sacral rectopexy with sutures or meshes
Sham Comparator: Non-pexy group; These patients will receive full rectal mobilization from the sacrum but without rectopexy	Procedure: full rectal mobilization from the sacrum without sacral rectopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
long term recurrence of the rectal prolapse	after 5 years

Collaborators and Investigators

• Sponsor: Societa Italiana di Chirurgia ColoRettale

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: recurrence; mesh; Rectal prolapse
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Rectal Prolapse
• Other Study ID Numbers: Berg.2007