Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Prolapse

Intervention / Treatment
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* Procedure: sacral rectopexy with sutures or meshes
* Procedure: full rectal mobilization from the sacrum without sacral rectopexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pexy group<br>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<br> <br> |
| Sham Comparator: Non-pexy group<br>These patients will receive full rectal mobilization from the sacrum but without rectopexy | Procedure: full rectal mobilization from the sacrum without sacral rectopexy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal prolapse, mesh, recurrence