Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00321867
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2006-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020047', 'term': 'Rectocele'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2006-05-03', 'studyFirstSubmitQcDate': '2006-05-03', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomic cure defined by standardized POPQ measures', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life based on PFIQ validated questionnaire', 'timeFrame': '12 months'}, {'measure': 'Sexual function', 'timeFrame': '12 months'}, {'measure': 'Patient centered goals', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rectocele', 'pelvic prolapse', 'graft', 'surgical repair'], 'conditions': ['Rectocele']}, 'referencesModule': {'references': [{'pmid': '22183220', 'type': 'RESULT', 'citation': 'Sung VW, Rardin CR, Raker CA, Lasala CA, Myers DL. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):125-33. doi: 10.1097/AOG.0b013e31823d407e.'}, {'pmid': '38477494', 'type': 'DERIVED', 'citation': 'Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024 Mar 13;3(3):CD012079. doi: 10.1002/14651858.CD012079.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.', 'detailedDescription': 'Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.\n\nComparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with stage 2 or greater symptomatic rectocele\n* Women electing to undergo surgical rectocele repair\n* Women over age 21 years\n* Women willing to comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* History of porcine allergy\n* History of connective tissue disease, pelvic malignancy, or pelvic radiation\n* Women undergoing concurrent sacral colpopexy'}, 'identificationModule': {'nctId': 'NCT00321867', 'briefTitle': 'Graft-Augmented Rectocele Repair-A Randomized Surgical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial', 'orgStudyIdInfo': {'id': '03-0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Native tissue repair', 'interventionNames': ['Procedure: Control']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Posterior repair with graft', 'interventionNames': ['Procedure: Graft augmented posterior repair']}], 'interventions': [{'name': 'Graft augmented posterior repair', 'type': 'PROCEDURE', 'description': 'Posterior repair with graft', 'armGroupLabels': ['2']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Native tissue repair', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women and Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Vivian W Sung, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Women and Infants Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vivian Sung', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}