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Traditional vs. Graft-augmented Posterior Colporrhaphy

Primary Purpose

Pelvic Organ Prolapse, Posterior Vaginal Wall Defects

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Graft-augmented colporrhaphy
Traditional posterior colporrhaphy
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Posterior wall defects, Graft-augmented repair, Posterior colporrhaphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of California, Irvine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Posterior repair with graft augmentation.

Posterior repair without graft augmentation.

Outcomes

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).

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.

Full Information

First Posted
December 20, 2007
Last Updated
January 22, 2021
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00581594
Brief Title
Traditional vs. Graft-augmented Posterior Colporrhaphy
Official Title
Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Could not meet recruitment, technology advancement.
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 11, 2008 (Actual)
Study Completion Date
October 11, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Posterior Vaginal Wall Defects
Keywords
Pelvic organ prolapse, Posterior wall defects, Graft-augmented repair, Posterior colporrhaphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Posterior repair with graft augmentation.
Arm Title
2
Arm Type
Other
Arm Description
Posterior repair without graft augmentation.
Intervention Type
Procedure
Intervention Name(s)
Graft-augmented colporrhaphy
Other Intervention Name(s)
Xenform® material
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional posterior colporrhaphy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L Noblett, M.D.
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

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Traditional vs. Graft-augmented Posterior Colporrhaphy

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