Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 6:16 AM
Study NCT ID:
NCT04939194
Status:
UNKNOWN
Last Update Posted:
2021-06-25
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay.', 'timeFrame': '3 months after surgery.', 'description': 'Mean length of hospital stay defined as days from admission to the hospital, in both groups 1 day before surgery and discharge.'}], 'secondaryOutcomes': [{'measure': 'Early postoperative complications rate defined and graded according to Clavien-Dindo system.', 'timeFrame': '3 months after surgery.', 'description': 'Rate of early postoperative complications eg: anastomotic leakage, intestinal obstruction, wound infection.'}, {'measure': 'Hospital readmission rate.', 'timeFrame': '3 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS (Early Recovery After Surgery)', 'Radical Cystectomy'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'We will design a randomized controlled single center study in which we will compare 2 groups of patients, 1 with standard perioperative protocols and another one in which we will apply fast track protocols in patients after radical cystectomy and urinary diversion .', 'detailedDescription': 'Study hypothesis:\n\nFast Track Protocol after Radical Cystectomy reduces the length of hospital stay and the early postoperative complications relative to the traditional perioperative care regimen.\n\nPurpose of the study:\n\n1. To evaluate the the perioperative efficacy, safety and benefits of fast track protocol implementation after radical cystectomy and to optimize perioperative patient care for the benefit of "fast-track" surgery.\n2. To evaluate early complications in patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion.\n\nStudy groups:\n\nGroup 1: Fast Track group (105 patients). Group 2: Conventional perioperative care group (105 patients).\n\nStudy design:\n\nThe design of the research will be a prospective randomised, open-label, controlled study on 210 consecutive patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion. All the patients will sign an informed consent. Length of stay, dietary issues, and return of bowel function, readmission rates and complications will be evaluated.\n\nStudy setting/location:\n\nThe study will be conducted in a single tertiary centre, Urology and Nephrology Centre in Mansoura, Egypt. The study will be carried out on patient with bladder cancer who will be subjected to radical cystectomy and urinary diversion.\n\nStudy duration:\n\nThe study will last about 2 and half years.\n\nRandomisation:\n\nRandomization will be performed using computer generated, sequentially numbered random tables. Ratio of assignment to groups is 1: 1.\n\nAllocation concealment and blinding:\n\nWe are well aware that it is very difficult to properly blind trials comparing surgical treatments. Allocation of patients to treatment groups will be self-evident following randomization and blinding of patient groups and observers will not be possible. So, our trial will be a randomised, open-label, controlled trial.\n\nType of analysis:\n\nIntention-to-treat analysis is planned in this trial. We will include all patients randomized to the fast track group regardless of their adherence and compliance to the early recovery after surgery (ERAS) items.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit\n\nExclusion Criteria:\n\n1. Radical cystectomy performed in an emergency setting\n2. Patients who refused fast track protocol\n3. Mental illnesses'}, 'identificationModule': {'nctId': 'NCT04939194', 'briefTitle': 'Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'UNC , Mansoura'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fast Track Protocol', 'description': 'the 22 items of ERAS (Early Recovery After Surgery) society', 'interventionNames': ['Behavioral: Fast Track Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional perioperative care program', 'description': 'standard perioperative care'}], 'interventions': [{'name': 'Fast Track Protocol', 'type': 'BEHAVIORAL', 'description': 'We will apply 22 items of ERAS society', 'armGroupLabels': ['Fast Track Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura Urology & Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed Mosbah, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt'}, {'name': 'Mahmoud Laymon, Lecturer.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt'}, {'name': 'Ahmed Lashin, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A.M.Lashin', 'investigatorFullName': 'Ahmed Mohammed Lashin', 'investigatorAffiliation': 'Mansoura University'}}}}