Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00321867

Enrollment

160

Registered

2006-05-04

Start date

2004-01-31

Completion date

2012-01-31

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectocele

Keywords

rectocele, pelvic prolapse, graft, surgical repair

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.

Interventions

PROCEDUREGraft augmented posterior repair

Posterior repair with graft

PROCEDUREControl

Native tissue repair

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Anatomic cure defined by standardized POPQ measures	12 months

Secondary

Measure	Time frame
Quality of life based on PFIQ validated questionnaire	12 months
Sexual function	12 months
Patient centered goals	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026