Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
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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 |
- Anatomic cure defined by standardized POPQ measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| 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: | December 19, 2012 |
| 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 May 16, 2013