Expired Study
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Orange, California 92868


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT00581594


Primary Contact:

Principal Investigator
Karen L Noblett, M.D.
University of California, Irvine


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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