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Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Primary Purpose

Rectocele

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Graft augmented posterior repair
Control
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectocele focused on measuring rectocele, pelvic prolapse, graft, surgical repair

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Women and Infants Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Native tissue repair

Posterior repair with graft

Outcomes

Primary Outcome Measures

Anatomic cure defined by standardized POPQ measures

Secondary Outcome Measures

Quality of life
Sexual function
Patient centered goals

Full Information

First Posted
May 3, 2006
Last Updated
May 27, 2014
Sponsor
Women and Infants Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT00321867
Brief Title
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Official Title
Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele
Keywords
rectocele, pelvic prolapse, graft, surgical repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Native tissue repair
Arm Title
2
Arm Type
Experimental
Arm Description
Posterior repair with graft
Intervention Type
Procedure
Intervention Name(s)
Graft augmented posterior repair
Intervention Description
Posterior repair with graft
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Native tissue repair
Primary Outcome Measure Information:
Title
Anatomic cure defined by standardized POPQ measures
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
12 months
Title
Sexual function
Time Frame
12 months
Title
Patient centered goals
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian W Sung, MD MPH
Organizational Affiliation
Women and Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22183220
Citation
Sung VW, Rardin CR, Raker CA, Lasala CA, Myers DL. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):125-33. doi: 10.1097/AOG.0b013e31823d407e.
Results Reference
result

Learn more about this trial

Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

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