Traditional vs. Graft-augmented Posterior Colporrhaphy

University of California Irvine (UCI)

Status: Terminated

Conditions: Posterior Vaginal Wall Defects; Pelvic Organ Prolapse

Treatments: Procedure: Graft-augmented colporrhaphy; Procedure: Traditional posterior colporrhaphy

Study type: Interventional

Funder types: Other

Identifiers

NCT00581594

2005-4574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

1

Other group

Description:

Posterior repair with graft augmentation.

Treatment:

Procedure: Graft-augmented colporrhaphy

2

Other group

Description:

Posterior repair without graft augmentation.

Treatment:

Procedure: Traditional posterior colporrhaphy