Graft-Augmented Rectocele Repair-A Randomized Surgical Trial - Full Text View

Sponsored by:	Women and Infants Hospital of Rhode Island
Information provided by:	Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:	NCT00321867

Purpose

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

Condition	Intervention
Rectocele	Procedure: Graft augmented rectocele repair Procedure: Traditional or site specific rectocele repair

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:

Anatomic cure defined by standardized POPQ measures

Secondary Outcome Measures:

Quality of life
Sexual function
Patient centered goals

Estimated Enrollment:	160
Study Start Date:	January 2004

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321867

Contacts

Contact: Vivian W Sung, MD MPH	401-453-7560 ext 111	vsung@wihri.org
Contact: Deborah L Myers, MD	401-453-7560	dmyers@wihri.org

Locations

United States, Rhode Island
Women and Infants Hospital of Rhode Island	Recruiting
Providence, Rhode Island, United States, 02905
Sub-Investigator: Charles R Rardin, MD
Sub-Investigator: Margaret S Hahn, RNP
Sub-Investigator: Deborah L Myers, MD

Sponsors and Collaborators

Women and Infants Hospital of Rhode Island

Investigators

Principal Investigator:

Vivian W Sung, MD MPH

Women and Infants Hospital

More Information

Responsible Party:	( Vivian W. Sung )
Study ID Numbers:	03-0086
Study First Received:	May 3, 2006
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00321867
Health Authority:	United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:

rectocele
pelvic prolapse
graft
surgical repair

Study placed in the following topic categories:

Rectocele
Digestive System Diseases
Gastrointestinal Diseases

Intestinal Diseases
Rectal Diseases
Prolapse

ClinicalTrials.gov processed this record on January 16, 2009