RectoceleNCT00321867
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
A study testing Graft augmented posterior repair in people with Rectocele, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Rectocele
- What is being tested?
- Graft augmented posterior repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or nursing women
- History of porcine allergy
- History of connective tissue disease, pelvic malignancy, or pelvic radiation
- Women undergoing concurrent sacral colpopexy
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized 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.
Read the 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.
- Conditions
- Rectocele
- Being tested
- Graft augmented posterior repair, Control
- Keywords
- rectocele, pelvic prolapse, graft, surgical repair
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graft augmented posterior repairProcedure or surgery
Posterior repair with graft
ControlProcedure or surgery
Native tissue repair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Native tissue repair Receives: Procedure: Control |
| 2 | Experimental | Posterior repair with graft Receives: Procedure: Graft augmented posterior repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic cure defined by standardized POPQ measures
Measured: 12 months
Secondary outcomes (3)
Quality of life based on PFIQ validated questionnaire
Measured: 12 months
Sexual function
Measured: 12 months
Patient centered goals
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startJan 2004
- Primary completionDec 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RectoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian Sung, Women and Infants Hospital of Rhode Island
- Investigators
- Vivian W Sung, MD MPH, Principal investigator, Women and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321867
- Sponsor's protocol ID
- 03-0086
- Status last verified
- Jul 2025
- First submitted
- 3 May 2006
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22183220Yeung 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.
PubMed 38477494
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
- ClinicalTrials.gov ID
- NCT00321867
- Acronym / sponsor ID
- 03-0086
- Conditions
- Rectocele
- Keywords
- rectocele, pelvic prolapse, graft, surgical repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: ControlNative tissue repair |
| 2 | Experimental | Procedure: Graft augmented posterior repairPosterior repair with graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or nursing women
- History of porcine allergy
- History of connective tissue disease, pelvic malignancy, or pelvic radiation
- Women undergoing concurrent sacral colpopexy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graft augmented posterior repairPosterior repair with graft | Procedure or surgery | 2 |
| ControlNative tissue repair | Procedure or surgery | 1 |
Primary outcome
Anatomic cure defined by standardized POPQ measures
Time frame: 12 months
3 secondary outcomes
Quality of life based on PFIQ validated questionnaire
Time frame: 12 months
Sexual function
Time frame: 12 months
Patient centered goals
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Results publication: PubMed 22183220Sung 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.
- Derived from this study: PubMed 38477494Yeung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian W Sung, MD MPH principal investigator
Women and Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graft augmented posterior repair in people with Rectocele, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic cure defined by standardized POPQ measures (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00321867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.