Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
Study NCT ID:
NCT04406168
Status:
UNKNOWN
Last Update Posted:
2020-05-28
First Post:
2020-05-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014547', 'term': 'Urinary Diversion'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients presented by complications', 'timeFrame': '1 year post operative', 'description': 'such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis )'}, {'measure': 'Rate of patients developed recurrence', 'timeFrame': '1 year post operative', 'description': 'recurrence of cancer'}, {'measure': 'Survival rate (overall survival & cancer specific)', 'timeFrame': '1 year post operative', 'description': 'patient live post operative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary tract. Both continent and incontinent diversions are available for urinary reconstruction after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous, ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves consideration of issues related to cancer stage, patient comorbidities, treatment needs, and patient desires related to Quality of life and intraoperative findings. Outcomes of urinary diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or post-operative).\n\nIn this study, all these outcomes will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All cases that fulfil the selection criteria that have been admitted in Asyut university urology hospital (non probability sample size) with expected size of 40 patients starting from 01/01/2013 to1/05/2020.\n\nAdditionally, the competence of follow-up will be approved by imaging and medical records.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\* All patients underwent radical cystectomy more than 1 year\n\nExclusion Criteria:\n\n* incomplete data\n* patients underwent RC outside urology department and presented for treatment of complications.'}, 'identificationModule': {'nctId': 'NCT04406168', 'briefTitle': 'Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital', 'orgStudyIdInfo': {'id': 'urinary diversions outcomes'}}, 'armsInterventionsModule': {'interventions': [{'name': 'urinary diversion', 'type': 'PROCEDURE', 'description': 'follow up outcomes of urinary diversion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11174', 'city': 'Asyut', 'state': 'Elgam3a', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'tarek m elgamaal', 'role': 'CONTACT'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'islam m abdellah', 'role': 'CONTACT', 'email': 'islam01183@med.au.edu.eg', 'phone': '+201090088672'}], 'overallOfficials': [{'name': 'salah s abdelhafez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'prof'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of urology', 'investigatorFullName': 'Islam Mahmoud Abdellah', 'investigatorAffiliation': 'Assiut University'}}}}