Status:
COMPLETED
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Rectocele
Eligibility:
FEMALE
21+ years
Phase:
NA
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.
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. Sur...
Eligibility Criteria
Inclusion
- 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
- Pregnant or nursing women
- History of porcine allergy
- History of connective tissue disease, pelvic malignancy, or pelvic radiation
- Women undergoing concurrent sacral colpopexy
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00321867
Start Date
January 1 2004
End Date
January 1 2012
Last Update
July 17 2025
Active Locations (1)
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1
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905