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

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ClinicalTrials.gov Identifier: NCT01022034
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : January 2003
Primary Completion Date : January 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: after 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

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