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

Societa Italiana di Chirurgia ColoRettale

Status and phase: Completed; Phase 3

Conditions: Rectal Prolapse

Treatments: Procedure: full rectal mobilization from the sacrum without sacral rectopexy; Procedure: sacral rectopexy with sutures or meshes

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01022034

Berg.2007

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Pexy group

Active Comparator group

Description:

This group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures

Treatment:

Procedure: sacral rectopexy with sutures or meshes

Non-pexy group

Sham Comparator group

Description:

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

Treatment:

Procedure: full rectal mobilization from the sacrum without sacral rectopexy