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NCT Number: NCT01022034

Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

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.

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Key information

Conditions

Rectal Prolapse Digestive System Diseases Disease Attributes Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases Recurrence

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stony brook University

New York, 11794-3368, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacral rectopexy with sutures or meshes

Procedure

full rectal mobilization from the sacrum without sacral rectopexy

Procedure

Primary outcomes

  1. long term recurrence of the rectal prolapse

    Time frame: after 5 years

Sponsors and collaborators

Lead sponsor

Societa Italiana di Chirurgia ColoRettale

Network

Registry information

Official study title

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

Acronym: Bergamaschi

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Dec 1, 2009
Registry last updated
Dec 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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