NCT00321867

Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Rectocele

Interventions

Type	Name	Description
PROCEDURE	Graft augmented posterior repair	Posterior repair with graft
PROCEDURE	Control	Native tissue repair

Timeline

• Start date: 2004-01-01
• Primary completion: 2010-12-01
• Completion: 2012-01-01
• First posted: 2006-05-04
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States