Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vivian Sung, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00321867
First received: May 3, 2006
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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
Rectocele
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00321867

Locations
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov 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:
rectocele
pelvic prolapse
graft
surgical repair

Additional relevant MeSH terms:
Rectocele
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014