Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT04129606
Status:
UNKNOWN
Last Update Posted:
2019-10-17
First Post:
2019-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000072662', 'term': 'Margins of Excision'}, {'id': 'D009366', 'term': 'Neoplasm Seeding'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-15', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of bladder perforation post-Transurethral resection of bladder tumour', 'timeFrame': '24 months', 'description': 'calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients'}], 'secondaryOutcomes': [{'measure': 'Correlation between the cystoscopical and radiological bladder perforation', 'timeFrame': '24 months', 'description': 'compare the numbers of bladder perforation diagnosed by CT cystogram by the number of bladder perforation described by surgeon'}, {'measure': 'assess the recurrence free rate in bladder perforation groups at 2 year follow up', 'timeFrame': '24 months', 'description': 'calculate the number of recurrence pf bladder tumor in bladder perforation at 2 year follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perforation of Bladder', 'Bladder Cancer', 'Resection Margin'], 'conditions': ['Bladder Cancer', 'Bladder Urothelial Carcinoma', 'Trauma', 'Injuries', 'Perforation of Bladder', 'Recurrence Tumor', 'Resection Margin', 'Seeding, Neoplasm']}, 'descriptionModule': {'briefSummary': 'In view of sparse data of precise definition, risk factors, natural history and management of bladder perforation following Transurethral resection of bladder tumour (TURBT). We aim to correlate the relation between the site, depth and extent of resection with bladder perforation. Also, correlation between vertical depth, horizontal extent of resection and recurrence and progression of tumor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* papillary bladder tumor (denovo or recurrent)\n* resectable nodular bladder tumor\n\nExclusion Criteria:\n\n* Refuse to complete study requirements\n* muscle invasive bladder tumor'}, 'identificationModule': {'nctId': 'NCT04129606', 'acronym': 'TURBT-BP', 'briefTitle': 'Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Bladder Perforation Post-TURBT: Definition, Incidence and Natural History. A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'TURBT-BP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TURBT', 'description': 'Transurethral resection of bladder tumour', 'interventionNames': ['Diagnostic Test: Computed tomographic cystography']}], 'interventions': [{'name': 'Computed tomographic cystography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CT cystography'], 'description': 'CT cystogram performed after the procedure by the injection of 400mL of 1/4 saline-diluted contrast solution (meglumine ioxitalamate) with low-pressure infusion (60 cm gravity pressure) through the Foley catheter.', 'armGroupLabels': ['TURBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Nasr Eltabey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abdelwahab Hashem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdelwahab Hashem', 'investigatorAffiliation': 'Mansoura University'}}}}