- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581594
Traditional vs. Graft-augmented Posterior Colporrhaphy
January 22, 2021 updated by: University of California, Irvine
Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study
Women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
The traditional approach to surgical repair of posterior wall defect is the posterior colporrhaphy.
Although this technique has been successful in the anatomic correction of the defect, the functional outcomes have been disappointing.
This fact suggests improvement in the functional and anatomic outcomes following a traditional posterior colporrhaphy.
Consequently, the idea of incorporating graft material into the repair to augment the patient's own tissue has been examined.
Placing a piece of graft material in between the vagina and rectum adds an extra layer of support and thus augments the strength of the repair.
The purpose of this study is to evaluate the anatomic and functional outcomes of posterior compartment, graft-augmented traditional posterior colporrhaphy vs. traditional posterior colporrhaphy alone.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Orange, California, United States, 92868
- University of California, Irvine Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age > 18 years old
- Posterior wall defect with point Ap or Bp at 0 or greater
- Desires surgical correction
- Willing to accept randomization to graft vs. no graft
- Competent to sign an informed consent
- Completed childbearing
- Non-pregnant
Exclusion Criteria:
- Current anal sphincter disruption with planned incontinent surgical repairs
- Poor surgical candidate
- History of rectal cancer or inflammatory bowel disease
- Current rectovaginal
- History of vaginal cancer
- History of vaginal/pelvic radiation
- Foreshortened vagina
- Previous adverse reaction to Xenform matrix graft material
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Posterior repair with graft augmentation.
|
Patients will undergo randomized surgical procedure.
Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall.
Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen.
Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver.
Patients will be seen at 6 months for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI.
Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse.
Patients will be seen at 1 year and yearly intervals up to five years for a pelvic exam for evaluation of posterior wall support and the questionnaires.
Other Names:
|
Other: 2
Posterior repair without graft augmentation.
|
Patients will undergo randomized surgical procedure.
Patients will be seen at 2 weeks for routine post-op care and evaluation of any post-op complications.
Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall.
Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen.
Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver.
Patients will be seen at 6 months, for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI.
Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse.
Patients will be seen at 1 year and yearly intervals up to five years to have a pelvic exam for evaluation of posterior wall support and the questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).
Time Frame: 5 Years
|
5 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary outcomes will be measuring the effects of the surgical repair on various aspects of life using a series of questionnaires: SF-36 as a measure of quality of life, PISQ to measure sexual function, and FISI to measure rectal function.
Time Frame: 5 Years
|
5 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen L Noblett, M.D., University of California, Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
October 11, 2008
Study Completion (Actual)
October 11, 2008
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 27, 2007
Study Record Updates
Last Update Posted (Actual)
January 25, 2021
Last Update Submitted That Met QC Criteria
January 22, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-4574
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pelvic Organ Prolapse
-
University of CalgaryAlberta Health services; Cook Group IncorporatedCompletedAnterior Pelvic Organ ProlapseCanada
-
Coloplast A/SCompletedPelvic Organ Prolapse (POP)United States
-
University of British ColumbiaCompletedPelvic Organ Prolapse, Patient EducationCanada
-
University of MelbourneCompletedVaginal Hysterectomy | Pelvic Organ Prolapse Vaginal SurgeryAustralia
-
Unity Health TorontoUnknownVoiding Dysfunction After Pelvic Organ Prolapse SurgeryCanada
-
Nykøbing Falster County HospitalZealand University Hospital; University Hospital, Gentofte, Copenhagen; Copenhagen...UnknownBenign Hysterectomy | Postoperative Pelvic Organ Prolapse | Suspension
-
Mackay Medical CollegeRecruitingPelvic Organ Prolapse | Stage III and IV High Grade Pelvic Organ ProlapseTaiwan
-
Peking Union Medical College HospitalUnknown
-
Gaziosmanpasa Research and Education HospitalRecruitingPatients With Pelvic Organ Prolapse | Pectopexy | Lateral Suspension | Pop-q | Pisq-12Turkey
-
Charles University, Czech RepublicUnknownPelvic Organ Prolapse RecurrenceCzech Republic
Clinical Trials on Graft-augmented colporrhaphy
-
Saint Petersburg State University, RussiaActive, not recruiting
-
NorthShore University HealthSystemCompletedPelvic Organ Prolapse
-
Ain Shams Maternity HospitalRecruitingPelvic Organ Prolapse | Rectocele; FemaleEgypt
-
Women and Infants Hospital of Rhode IslandCompleted
-
Hillel Yaffe Medical CenterUnknown
-
Radboud University Medical CenterUnknownPelvic Organ Prolapse | Cystocele | Uterine Prolapse | RectoceleNetherlands
-
National Taiwan University HospitalActive, not recruitingProlapse; FemaleTaiwan
-
Seoul National University HospitalActive, not recruitingPelvic Organ ProlapseKorea, Republic of
-
Institute of Gynecology, Inc.CompletedGynecological Disorder
-
Halla Gamal Mohammed EsmailNot yet recruiting