Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Rectocele

Clinical Trial Details

NCT number	NCT00321867
Study type	Interventional
Source	Women and Infants Hospital of Rhode Island
Contact
Status	Completed
Phase	N/A
Start date	January 2004
Completion date	January 2012

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