Traditional vs. Graft-augmented Posterior Colporrhaphy

Not Applicable

Terminated

• Conditions: Posterior Vaginal Wall Defects; Pelvic Organ Prolapse
• Interventions: Procedure: Traditional posterior colporrhaphy; Procedure: Graft-augmented colporrhaphy

• Registration Number: NCT00581594
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-27
• Primary Completion: 2008-10-11
• Study Completion: 2008-10-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Traditional posterior colporrhaphy	Posterior repair without graft augmentation.
1	Graft-augmented colporrhaphy	Posterior repair with graft augmentation.

Primary Outcome Measures

Name	Time	Method
The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).	5 Years

Secondary Outcome Measures

Name	Time	Method
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.	5 Years

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States