Bergamaschi: Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

• Sponsor: Societa Italiana di Chirurgia ColoRettale (Other)
• Overall Status: Completed
• CT.gov ID: NCT01022034
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Duration (Months): 81
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse	Procedure: sacral rectopexy with sutures or meshes; Procedure: full rectal mobilization from the sacrum without sacral rectopexy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. long term recurrence of the rectal prolapse [after 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony brook University	New York	New York	United States	11794-3368

Sponsors and Collaborators

• Societa Italiana di Chirurgia ColoRettale

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01022034
• Other Study ID Numbers: Berg.2007
• First Posted: Dec 1, 2009
• Last Update Posted: Dec 2, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Rectal prolapse; mesh; recurrence
• Additional relevant MeSH terms: Rectal Prolapse; Prolapse

Study Results

No Results Posted as of Dec 2, 2009