Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal