Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

• Sponsor: Women and Infants Hospital of Rhode Island (Other)
• Overall Status: Completed
• CT.gov ID: NCT00321867
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectocele	Procedure: Graft augmented posterior repair; Procedure: Control	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Native tissue repair	Procedure: Control; Native tissue repair
Experimental: 2 Posterior repair with graft	Procedure: Graft augmented posterior repair; Posterior repair with graft

Outcome Measures

Primary Outcome Measures

1. Anatomic cure defined by standardized POPQ measures [12 months]

Secondary Outcome Measures

1. Quality of life [12 months]

2. Sexual function [12 months]

3. Patient centered goals [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women and Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905

Sponsors and Collaborators

• Women and Infants Hospital of Rhode Island

Investigators

• Principal Investigator: Vivian W Sung, MD MPH, Women and Infants Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island
• ClinicalTrials.gov Identifier: NCT00321867
• Other Study ID Numbers: 03-0086
• First Posted: May 4, 2006
• Last Update Posted: May 28, 2014
• Last Verified: May 1, 2014

• Keywords provided by Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island: rectocele; pelvic prolapse; graft; surgical repair
• Additional relevant MeSH terms: Rectocele

Study Results

No Results Posted as of May 28, 2014