Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

July 14, 2025 updated by: Vivian Sung, Women and Infants Hospital of Rhode Island

Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial

The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.

Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women with stage 2 or greater symptomatic rectocele
  • Women electing to undergo surgical rectocele repair
  • Women over age 21 years
  • Women willing to comply with study procedures and follow-up

Exclusion Criteria:

  • Pregnant or nursing women
  • History of porcine allergy
  • History of connective tissue disease, pelvic malignancy, or pelvic radiation
  • Women undergoing concurrent sacral colpopexy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Native tissue repair
Procedure: Control
Native tissue repair
Experimental: 2
Posterior repair with graft
Procedure: Graft augmented posterior repair
Posterior repair with graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anatomic cure defined by standardized POPQ measures
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sexual function
Time Frame: 12 months
12 months
Patient centered goals
Time Frame: 12 months
12 months
Quality of life based on PFIQ validated questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Vivian W Sung, MD MPH, Women and Infants Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 3, 2006

First Posted (Estimated)

May 4, 2006

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-0086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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