Traditional vs. Graft-augmented Posterior Colporrhaphy
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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.
Condition | Intervention |
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Pelvic Organ Prolapse Posterior Vaginal Wall Defects |
Procedure: Graft-augmented colporrhaphy Procedure: Traditional posterior colporrhaphy |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Official Title: | Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 128 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Posterior repair with graft augmentation.
|
Procedure: Graft-augmented colporrhaphy
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 Name: Xenform® material
|
2
Posterior repair without graft augmentation.
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Procedure: Traditional posterior colporrhaphy
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, California | |
University of California, Irvine Medical Center | |
Orange, California, United States, 92868 |
Principal Investigator: | Karen L Noblett, M.D. | University of California, Irvine |
No publications provided
Responsible Party: | Karen Noblett, Associate Professor, University of California, Irvine Medical Center |
ClinicalTrials.gov Identifier: | NCT00581594 History of Changes |
Other Study ID Numbers: | 2005-4574 |
Study First Received: | December 20, 2007 |
Last Updated: | August 5, 2010 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
Pelvic organ prolapse Posterior wall defects Graft-augmented repair Posterior colporrhaphy |
Additional relevant MeSH terms:
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on October 17, 2012