Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.

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Detailed Description

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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

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Rectocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Native tissue repair

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Native tissue repair

2

Posterior repair with graft

Group Type EXPERIMENTAL

Graft augmented posterior repair

Intervention Type PROCEDURE

Posterior repair with graft

Interventions

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Graft augmented posterior repair

Posterior repair with graft

Intervention Type PROCEDURE

Control

Native tissue repair

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No