Pexy Versus Non-pexy for Full Thickness Rectal Prolapse (Bergamaschi)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rectal Prolapse |
Procedure: sacral rectopexy with sutures or meshes Procedure: full rectal mobilization from the sacrum without sacral rectopexy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial |
- long term recurrence of the rectal prolapse [ Time Frame: after 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2003 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Roberto Bergamaschi MD, PhD, FRCS, State Univeristy of New York , Stony Brook |
| ClinicalTrials.gov Identifier: | NCT01022034 History of Changes |
| Other Study ID Numbers: | Berg.2007 |
| Study First Received: | November 25, 2009 |
| Last Updated: | December 1, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Societa Italiana di Chirurgia ColoRettale:
|
Rectal prolapse mesh recurrence |
Additional relevant MeSH terms:
|
Prolapse Rectal Prolapse Pathological Conditions, Anatomical Rectal Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Pelvic Organ Prolapse |
ClinicalTrials.gov processed this record on May 22, 2013