Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

NCT01022034 | Completed Phase 3

• 1 other identifier: Berg.2007
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Prolapse

Keywords

Rectal prolapse; mesh; recurrence

Outcome Measures

Primary Outcomes (1)

• long term recurrence of the rectal prolapse

  after 5 years

Study Arms (2)

Pexy group

ACTIVE COMPARATOR

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

Non-pexy group

SHAM COMPARATOR

These patients will receive full rectal mobilization from the sacrum but without rectopexy

Procedure: full rectal mobilization from the sacrum without sacral rectopexy

Interventions

sacral rectopexy with sutures or meshes PROCEDURE

Pexy group

full rectal mobilization from the sacrum without sacral rectopexy PROCEDURE

Non-pexy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• mental ability to understand the procedure
• age range 18 to 70
• both sex

You may not qualify if:

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

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead

Study Sites (1)

Stony brook University

New York, New York, 11794-3368, United States

Location

MeSH Terms

Conditions

Rectal Prolapse; Recurrence

Interventions

Sutures

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: December 1, 2009
• Study Start: January 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

US (1)