Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT06147804
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-18', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-18', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the surgical managment of the bladder tear', 'timeFrame': 'Follow up after 3 weeks and 3 months and 6 months', 'description': 'By the occurrence of vesicogenital fistula or not\n\nevaluate the prevalence of vesicogenital fistula after bladder trauma after gynaecological and obstetric operations'}], 'secondaryOutcomes': [{'measure': 'To evaluate the quality of life, satisfaction of patients, UTI manifestations', 'timeFrame': 'After 3 weeks and 3 months and 6 months', 'description': 'By directly questioning the patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary bladder trauma after gynaecological and obstetric operations'], 'conditions': ['Urinary Bladder Trauma']}, 'descriptionModule': {'briefSummary': 'We aimed to evaluate the management and outcome of bladder trauma after gynecological and obstetric operations at Assiut university hospital and to evaluate the methods of treatment of these complications.\n\nWe aimed to find out risk factors for vesico uterine fistula after bladder trauma', 'detailedDescription': 'The female genital and urinary systems are closely related embryologically and anatomically. The surgeon should know the anatomy of this area to avoid urinary tract (UT) injuries during obstetric (Obst) and gynecologic (Gyn) surgeries (Solyman et al., 2022)\n\nUT injuries during Obst/Gyn surgeries are rare but have a significant psychological impact on both patient and surgeon, and their medico legal aspects are very bothering (Safrai et al., 2022)\n\nUT injuries during Obst/Gyn operations range from 0.3 to 1% (Blackwell et al., 2018) Most cases are bladder injury, approximately three times more than ureteral injury (Wong et al., 2018)\n\nThe primary goal of the Obst/Gyn surgeon is to avoid UT injuries during his procedure. Still, in some situations, this will be difficult as in patients with abnormal anatomy, difficult operations as in the presence of severe bleeding or pelvic adhesions, and with surgeons with low experience. Immediate intraoperative repair of these injuries is optimal. In some cases, diagnosis and management are delayed postoperatively(Patel and Heisler, 2021)\n\nUT injuries during Obst/Gyn operations are either acute injuries such as bladder and ureteral laceration, and ureteral ligation identified immediately intra operatively or chronic injuries as fistula formation and stricture ureter, which are discovered later on (Lee et al., 2012) Iatrogenic urological complications from gynecological surgery can be prevented and reduced by complying with standard surgical'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nAll patients with Urinary bladder injuries related to Obst/Gyn operations\n\nExclusion Criteria:\n\n* no exclusion criteria in all patients with bladder trauma after gyn \\&obs operations'}, 'identificationModule': {'nctId': 'NCT06147804', 'briefTitle': 'Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations', 'orgStudyIdInfo': {'id': 'UB trauma after gyn&obs op'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Females after gynaecological and obstetric operations', 'description': 'Comaprison of the outcome', 'interventionNames': ['Procedure: Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation']}], 'interventions': [{'name': 'Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation', 'type': 'PROCEDURE', 'description': 'How to manage Urinary bladder trauma after gynaecological and obstetric operations by the best method to prevent the occurrnce of vesicouterine fistula', 'armGroupLabels': ['Females after gynaecological and obstetric operations']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Hamdallah', 'role': 'CONTACT', 'email': 'Mohamed.15235465@med.aun.edu.eg', 'phone': '01009702496'}, {'name': 'Mahmoud Farok', 'role': 'CONTACT', 'email': 'Mahmodfarok11@yahoo.com', 'phone': '+20 100 915 2070'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Mohamed Ashraf Abdelmageed Hamdallah', 'investigatorAffiliation': 'Assiut University'}}}}