NCT00321867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

6.9 years

First QC Date

May 3, 2006

Last Update Submit

July 14, 2025

Conditions

Rectocele

Keywords

rectocelepelvic prolapsegraftsurgical repair

Outcome Measures

Primary Outcomes (1)

  • Anatomic cure defined by standardized POPQ measures

    12 months

Secondary Outcomes (3)

  • Quality of life based on PFIQ validated questionnaire

    12 months

  • Sexual function

    12 months

  • Patient centered goals

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Native tissue repair

Procedure: Control

2

EXPERIMENTAL

Posterior repair with graft

Procedure: Graft augmented posterior repair

Interventions

Graft augmented posterior repairPROCEDURE

Posterior repair with graft

2
ControlPROCEDURE

Native tissue repair

1

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or nursing women
  • History of porcine allergy
  • History of connective tissue disease, pelvic malignancy, or pelvic radiation
  • Women undergoing concurrent sacral colpopexy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (2)

  • 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.

    PMID: 22183220RESULT

  • 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.

    PMID: 38477494DERIVED

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Vivian W Sung, MD MPH

    Women and Infants Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2006

First Posted

May 4, 2006

Study Start

January 1, 2004

Primary Completion

December 1, 2010

Study Completion

January 1, 2012

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

US(1)