Traditional vs. Graft-augmented Posterior Colporrhaphy

Sponsor

University of California, Irvine (Other)

Overall Status

Terminated

CT.gov ID

NCT00581594

Collaborator

(none)

Enrollment

Location

Arms

33.3

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Posterior Vaginal Wall Defects	Procedure: Graft-augmented colporrhaphy Procedure: Traditional posterior colporrhaphy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Oct 11, 2008

Actual Study Completion Date :

Oct 11, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Xenform® material
Other: 2 Posterior repair without graft augmentation.	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.

Arm

Intervention/Treatment

Other: 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 Names:

Xenform® material

Other: 2

Posterior repair without graft augmentation.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

University of California, Irvine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Irvine

ClinicalTrials.gov Identifier:

NCT00581594

Other Study ID Numbers:

2005-4574

First Posted:

Dec 27, 2007

Last Update Posted:

Jan 25, 2021

Last Verified:

Jan 1, 2021

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

Study Results

No Results Posted as of Jan 25, 2021