Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT00581594
Status:
TERMINATED
Last Update Posted:
2021-01-25
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional vs. Graft-augmented Posterior Colporrhaphy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Could not meet recruitment, technology advancement.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2008-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).', 'timeFrame': '5 Years'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '5 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pelvic organ prolapse', 'Posterior wall defects', 'Graft-augmented repair', 'Posterior colporrhaphy'], 'conditions': ['Pelvic Organ Prolapse', 'Posterior Vaginal Wall Defects']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Posterior wall defect with point Ap or Bp at 0 or greater\n* Desires surgical correction\n* Willing to accept randomization to graft vs. no graft\n* Competent to sign an informed consent\n* Completed childbearing\n* Non-pregnant\n\nExclusion Criteria:\n\n* Current anal sphincter disruption with planned incontinent surgical repairs\n* Poor surgical candidate\n* History of rectal cancer or inflammatory bowel disease\n* Current rectovaginal\n* History of vaginal cancer\n* History of vaginal/pelvic radiation\n* Foreshortened vagina\n* Previous adverse reaction to Xenform matrix graft material'}, 'identificationModule': {'nctId': 'NCT00581594', 'briefTitle': 'Traditional vs. Graft-augmented Posterior Colporrhaphy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study', 'orgStudyIdInfo': {'id': '2005-4574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Posterior repair with graft augmentation.', 'interventionNames': ['Procedure: Graft-augmented colporrhaphy']}, {'type': 'OTHER', 'label': '2', 'description': 'Posterior repair without graft augmentation.', 'interventionNames': ['Procedure: Traditional posterior colporrhaphy']}], 'interventions': [{'name': 'Graft-augmented colporrhaphy', 'type': 'PROCEDURE', 'otherNames': ['Xenform® material'], '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.', 'armGroupLabels': ['1']}, {'name': 'Traditional posterior colporrhaphy', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Karen L Noblett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}