Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

Rectal Prolapse Clinical Trial

— Bergamaschi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022034
• Other study ID #: Berg.2007
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2009
• Last updated: December 1, 2009
• Start date: January 2003
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• sacral rectopexy with sutures or meshes

• full rectal mobilization from the sacrum without sacral rectopexy

Locations

Country	Name	City	State
United States	Stony brook University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long term recurrence of the rectal prolapse		after 5 years	No