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Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

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. Identifier: NCT00321867
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
Vivian Sung, Women and Infants Hospital of Rhode Island

Brief Summary:
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 or disease Intervention/treatment Phase
Rectocele Procedure: Graft augmented posterior repair Procedure: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
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
Study Start Date : January 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
  2. Sexual function [ Time Frame: 12 months ]
  3. Patient centered goals [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00321867

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

Publications of Results:
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Responsible Party: Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island Identifier: NCT00321867     History of Changes
Other Study ID Numbers: 03-0086
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Keywords provided by Vivian Sung, Women and Infants Hospital of Rhode Island:
pelvic prolapse
surgical repair
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical