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NCT00321867 Clinical Trial

Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Rectocele Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00321867
Other study ID # 03-0086
Secondary ID
Status Completed
Phase N/A
First received May 3, 2006
Last updated May 27, 2014
Start date January 2004
Est. completion date January 2012

Study information
Verified date May 2014
Source Women and Infants Hospital of Rhode Island
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date January 2012
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Graft augmented posterior repair
Posterior repair with graft
• Control
Native tissue repair

Locations
Country Name City State
United States Women and Infants Hospital of Rhode Island Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sung VW, Rardin CR, Raker CA, Lasala CA, Myers DL. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):125-33. doi: 10.1097/AOG.0b013e31823d407e. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Anatomic cure defined by standardized POPQ measures 12 months No
Secondary Quality of life 12 months No
Secondary Sexual function 12 months No
Secondary Patient centered goals 12 months No
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