Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03489902
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transvaginal Versus Transobturator Paravaginal Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052858', 'term': 'Cystocele'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-06', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative data', 'timeFrame': '1 day', 'description': 'Operative time'}], 'secondaryOutcomes': [{'measure': 'Pelvic organ prolapse quantification system', 'timeFrame': '3 month', 'description': 'Evaluation of the postoperative degree of anterior vaginal wall descent'}, {'measure': 'Operative Details', 'timeFrame': '1 day', 'description': 'blood loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystocele']}, 'descriptionModule': {'briefSummary': 'Clinical trial comparing the new technique for paravaginal repair versus the traditional technique', 'detailedDescription': 'trial comparing the transobturator paravaginal repair versus the traditional technique'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nparavaginal defect cystocele\n\nmidline and paravaginal defect cystocele\n\nExclusion Criteria:\n\n* uterine descent previous cystocele surgery'}, 'identificationModule': {'nctId': 'NCT03489902', 'briefTitle': 'Transvaginal Versus Transobturator Paravaginal Repair', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Transvaginal Versus Transobturator Paravaginal Repair Trial', 'orgStudyIdInfo': {'id': 'TVTOPVR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transobturator arm', 'description': 'Transobturator Paravaginal Repair', 'interventionNames': ['Procedure: Transobturator Paravaginal Repair']}, {'type': 'EXPERIMENTAL', 'label': 'Transvaginal arm', 'description': 'traditional transvaginal Paravaginal Repair', 'interventionNames': ['Procedure: traditional transvaginal Paravaginal Repair']}], 'interventions': [{'name': 'Transobturator Paravaginal Repair', 'type': 'PROCEDURE', 'description': 'Transobturator application of sutures to the white line in cases needing paravaginal repair', 'armGroupLabels': ['Transobturator arm']}, {'name': 'traditional transvaginal Paravaginal Repair', 'type': 'PROCEDURE', 'description': 'traditional transvaginal application of sutures to the white line', 'armGroupLabels': ['Transvaginal arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hamdy HA Saaid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow of obstetrics & gynecology', 'investigatorFullName': 'Hamdy Ahmed Saaid', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}