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Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00321867
First Posted: May 4, 2006
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vivian Sung, Women and Infants Hospital of Rhode Island
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Vivian Sung, Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Anatomic cure defined by standardized POPQ measures [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ]
  • Sexual function [ Time Frame: 12 months ]
  • Patient centered goals [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
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): 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

Publications:
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
First Submitted: May 3, 2006
First Posted: May 4, 2006
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Vivian Sung, 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
Hernia
Pathological Conditions, Anatomical