Graft-Augmented Rectocele Repair-A Randomized Surgical Trial | NCT00321867

Studies
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

NCT00321867

Sponsor

Women and Infants Hospital of Rhode Island

Status

Completed

Last Update Posted

Jul 17, 2025Actual

Enrollment

160Actual

Phase

Not Applicable

Conditions

Rectocele

Interventions

Graft augmented posterior repair
Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2012Actual

First Submitted Date

May 3, 2006

First Submission Date that Met QC Criteria

May 3, 2006

First Posted Date

May 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2025

Last Update Posted Date

Jul 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode IslandPrincipal Investigator

Lead Sponsor

Women and Infants Hospital of Rhode IslandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Native tissue repair	Procedure: Control
2	Experimental	Posterior repair with graft	Procedure: Graft augmented posterior repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Graft augmented posterior repair	Procedure	Posterior repair with graft	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomic cure defined by standardized POPQ measures		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivian W Sung, MD MPH	Women and Infants Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women and Infants Hospital of Rhode Island		Providence	Rhode Island	02905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22183220	Result	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.
38477494	Derived	Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024 Mar 13;3(3):CD012079. doi: 10.1002/14651858.CD012079.pub2.

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases