CompletedNot Applicable

Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

United States160 participantsStarted 2004-01

Plain-language 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.

Who can participate

Age range21 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Anatomic cure defined by standardized POPQ measures

Timeframe: 12 months

Trial details

NCT IDNCT00321867

SponsorWomen and Infants Hospital of Rhode Island

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

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