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

This study has been completed.
Sponsor:
Information provided by:
Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier:
NCT01022034
First received: November 25, 2009
Last updated: December 1, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by Societa Italiana di Chirurgia ColoRettale:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022034

Locations
United States, New York
Stony brook University
New York, New York, United States, 11794-3368
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
  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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014