| December 20, 2007 |
| June 11, 2009 |
| January 2006 |
| December 2011 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00581594 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| Traditional vs. Graft-Augmented Posterior Colporrhaphy |
| 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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
- Pelvic Organ Prolapse
- Posterior Vaginal Wall Defects
|
- Procedure: Graft-augmented colporrhaphy
- Procedure: Traditional posterior colporrhaphy
|
- Other: Posterior repair with graft augmentation.
- Other: Posterior repair without graft augmentation.
|
| |
| |
| Withdrawn |
| 128 |
| December 2011 |
| December 2011 (final data collection date for primary outcome measure) |
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
|
| Female |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00581594 |
| Karen Noblett, Associate Professor, University of California, Irvine Medical Center |
| 2005-4574 |
| University of California, Irvine |
|
| Principal Investigator: |
Karen L Noblett, M.D. |
University of California, Irvine Medical Center |
|
|
| University of California, Irvine |
| June 2009 |