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Sponsored by: |
Women and Infants Hospital of Rhode Island |
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Information provided by: | Women and Infants Hospital of Rhode Island |
ClinicalTrials.gov Identifier: | NCT00321867 |
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 |
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Rectocele |
Procedure: Graft augmented rectocele repair Procedure: Traditional or site specific rectocele repair |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial |
Estimated Enrollment: | 160 |
Study Start Date: | January 2004 |
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:
Exclusion Criteria:
Contact: Vivian W Sung, MD MPH | 401-453-7560 ext 111 | vsung@wihri.org |
Contact: Deborah L Myers, MD | 401-453-7560 | dmyers@wihri.org |
United States, Rhode Island | |
Women and Infants Hospital of Rhode Island | Recruiting |
Providence, Rhode Island, United States, 02905 | |
Sub-Investigator: Charles R Rardin, MD | |
Sub-Investigator: Margaret S Hahn, RNP | |
Sub-Investigator: Deborah L Myers, MD |
Principal Investigator: | Vivian W Sung, MD MPH | Women and Infants Hospital |
Responsible Party: | ( Vivian W. Sung ) |
Study ID Numbers: | 03-0086 |
Study First Received: | May 3, 2006 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00321867 |
Health Authority: | United States: Institutional Review Board |
rectocele pelvic prolapse graft surgical repair |
Rectocele Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Rectal Diseases Prolapse |