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Completed

NCT Number: NCT00321867

Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

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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Key information

Conditions

Rectocele Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Graft augmented posterior repair

Procedure

Posterior repair with graft

Control

Procedure

Native tissue repair

Primary outcomes

  1. Anatomic cure defined by standardized POPQ measures

    Time frame: 12 months

Secondary outcomes

  1. Quality of life based on PFIQ validated questionnaire

    Time frame: 12 months

  2. Sexual function

    Time frame: 12 months

  3. Patient centered goals

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2010
Study completion
2012
First posted
May 4, 2006
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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