Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT07279792
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D006982', 'term': 'Hypertonic Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of Recurrence', 'timeFrame': '6 months'}, {'measure': 'Risk of progression of bladder cancer', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder (Urothelial, Transitional Cell) Cancer', 'Nonmuscle Invasive Bladder Cancer', 'Irrigation', 'Hypertonic Saline', 'Normal Saline', 'Distilled Water', 'Continuous Bladder Irrigation']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will evaluate the efficacy of three bladder irrigation solutions - distilled water (DW), normal saline (NS), and hypertonic saline (HS) - as continuous bladder irrigation (CBI) following transurethral resection of non-muscle invasive bladder cancer (NMIBC). Short term (6 months) recurrence and progression free survival are mainly evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of non-muscle invasive urinary bladder urothelial carcinoma amenable for complete resection\n\nExclusion Criteria:\n\n* Patients with post-operative complications that need prolonged irrigation.\n* Patient who underwent incomplete resection during TURBT.\n* When large bladder perforation was suspected during TURBT.\n* Patients with chronic kidney disease.\n* Muscle invasive disease'}, 'identificationModule': {'nctId': 'NCT07279792', 'briefTitle': "Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection", 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': "Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection", 'orgStudyIdInfo': {'id': 'FMASU MS 685/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Bladder Irrigation with distilled water', 'interventionNames': ['Drug: Continuous Bladder Irrigation with distilled water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Bladder Irrigation with normal saline', 'interventionNames': ['Drug: Continuous Bladder Irrigation with normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Bladder Irrigation with hypertonic saline', 'interventionNames': ['Drug: Continuous Bladder Irrigation with hypertonic saline']}], 'interventions': [{'name': 'Continuous Bladder Irrigation with distilled water', 'type': 'DRUG', 'description': 'Continuous Bladder Irrigation with distilled water post non muscle invasive bladder cancer urethral resection by endoscopy', 'armGroupLabels': ['Continuous Bladder Irrigation with distilled water']}, {'name': 'Continuous Bladder Irrigation with normal saline', 'type': 'DRUG', 'description': 'Continuous Bladder Irrigation with normal saline post non muscle invasive bladder cancer urethral resection by endoscopy', 'armGroupLabels': ['Continuous Bladder Irrigation with normal saline']}, {'name': 'Continuous Bladder Irrigation with hypertonic saline', 'type': 'DRUG', 'description': 'Continuous Bladder Irrigation with hypertonic saline post non muscle invasive bladder cancer urethral resection by endoscopy', 'armGroupLabels': ['Continuous Bladder Irrigation with hypertonic saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}