Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 6:58 PM
Study NCT ID:
NCT06803160
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-31
First Post:
2025-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2025-01-26', 'studyFirstSubmitQcDate': '2025-01-26', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of operation', 'timeFrame': '6 months', 'description': 'Success of operation with excision of fistula in upcoming CT cystogram'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Success of Operation']}, 'descriptionModule': {'briefSummary': '• The aim of this study is to compare between laparoscopic combined trans-vesical and extravesical versus laparoscopic extravesical fistula excision in uterovesical fistula repair.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "* This is a retrospective study involving the retrieval and analysis of medical records of uterovesical patients who were managed at the Urology and Gynecology departments at Ain Shams University Hospitals.\n* Patient's records that were included in the study satisfied the following criteria:\n\n * The patient was diagnosed with uterovesical fistula.\n * The patient had laparoscopic surgery with either approach at the Urology and Gynecology departments at Ain Shams University Hospitals.\n * The fistulous track was confirmed and had been repaired.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients diagnosed with uterovesical fistula with history of uterine cesarean section or any urogenital surgery complaining of amenorrhea, cyclic hematuria, with or without urinary incontinence.\n\nExclusion Criteria:\n\n* • Pregnant females.\n\n * Patients who refuse to participate in the study.\n * Patients with concomitant pathology that could affect symptoms e.g., polycystic ovary disease, stress incontinence, bladder cancer or overactive bladder.\n * Patients with malignant fistula.'}, 'identificationModule': {'nctId': 'NCT06803160', 'briefTitle': 'Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'Lap Uterovesical Fistula'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopic Combined Fistula Excision of Uterovesical Fistula', 'description': 'Patinets who underwent Laparoscopic Combined Fistula Excision of Uterovesical Fistula', 'interventionNames': ['Procedure: Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula', 'Procedure: Laparoscopic Combined Fistula Excision of Uterovesical Fistula']}], 'interventions': [{'name': 'Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula', 'type': 'PROCEDURE', 'description': '• In extravesical approach, the posterior bladder wall and the anterior uterine wall around the fistula will be dissected. Scar tissue around the orifice of the fistula will be removed and trimmed. After suturing uterine and bladder wall, intervening omentum will be placed in-between.', 'armGroupLabels': ['Laparoscopic Combined Fistula Excision of Uterovesical Fistula']}, {'name': 'Laparoscopic Combined Fistula Excision of Uterovesical Fistula', 'type': 'PROCEDURE', 'description': '• In the combined approach, bladder will be opened bivalved till the site of the fistula. Scar tissue around the orifice of the fistula will be removed and trimmed. Careful dissection around the bladder and uterus will be done to suture both walls and place an intervening omentum in-between.', 'armGroupLabels': ['Laparoscopic Combined Fistula Excision of Uterovesical Fistula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mahmoud HossamEldin Saad Abdelhamid', 'investigatorFullName': 'Mahmoud Hossam', 'investigatorAffiliation': 'Ain Shams University'}}}}