Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

This study has been completed.
Information provided by (Responsible Party):
Vivian Sung, Women and Infants Hospital of Rhode Island Identifier:
First received: May 3, 2006
Last updated: June 11, 2013
Last verified: June 2013

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

Condition Intervention
Procedure: Graft augmented posterior repair
Procedure: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial

Resource links provided by NLM:

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Anatomic cure defined by standardized POPQ measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient centered goals [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 2004
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00321867

United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Principal Investigator: Vivian W Sung, MD MPH Women and Infants Hospital
  More Information

No publications provided by Women and Infants Hospital of Rhode Island

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island Identifier: NCT00321867     History of Changes
Other Study ID Numbers: 03-0086
Study First Received: May 3, 2006
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
pelvic prolapse
surgical repair

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 22, 2014