Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Not Applicable

Completed

• Conditions: Rectocele
• Interventions: Procedure: Control; Procedure: Graft augmented posterior repair

• Registration Number: NCT00321867
• Lead Sponsor: Women and Infants Hospital of Rhode Island

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. 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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-05-03
• Study First Submitted QC: 2006-05-03
• Study First Posted: 2006-05-04
• Primary Completion: 2010-12
• Study Completion: 2012-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Control	Native tissue repair
2	Graft augmented posterior repair	Posterior repair with graft

Primary Outcome Measures

Name	Time	Method
Anatomic cure defined by standardized POPQ measures	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months
Sexual function	12 months
Patient centered goals	12 months

Trial Locations

Locations (1)

Women and Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States