Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-26 @ 2:14 PM
Study NCT ID:
NCT03434132
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2018-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire', 'timeFrame': '6 months', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-C30 questionnaire', 'timeFrame': '6 months', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire', 'timeFrame': '12 months', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-C30 questionnaire', 'timeFrame': '12 months', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire', 'timeFrame': '24 months', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-C30 questionnaire', 'timeFrame': '24 months', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Disease free survival', 'timeFrame': '24 months', 'description': 'Comparison between open and robitic arms'}, {'measure': 'Cancer specific survival', 'timeFrame': '24 months', 'description': 'Comparison between open and robitic arms'}, {'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'Comparison between open and robitic arms'}, {'measure': 'Assessment of urinary continence with pad test.', 'timeFrame': '12 months', 'description': 'Comparison between open and robotic arms'}, {'measure': 'Assessment of urinary continence with pad test.', 'timeFrame': '24 months', 'description': 'Comparison between open and robotic arms'}], 'primaryOutcomes': [{'measure': 'Number of participants requiring perioperative transfusions.', 'timeFrame': '30 days', 'description': '50% reduction of perioperative transfusion rates in robotic arm.'}], 'secondaryOutcomes': [{'measure': 'Number of participants requiring insertion of nasogastric tube', 'timeFrame': '30 days', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.', 'timeFrame': '30 days', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.', 'timeFrame': '90 days', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.', 'timeFrame': '180 days', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Incidence of patients requiring readmission.', 'timeFrame': '90 days', 'description': 'Comparison between open and robotic arms.'}, {'measure': 'Cost analysis.', 'timeFrame': '30 days', 'description': 'Comparison between open and robotic arms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open Radical Cystectomy', 'Robotic Radical cystectomy', 'Intracorporeal urinary diversion', 'Prospective randdomized trial'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '33712389', 'type': 'DERIVED', 'citation': 'Mastroianni R, Tuderti G, Anceschi U, Bove AM, Brassetti A, Ferriero M, Zampa A, Giannarelli D, Guaglianone S, Gallucci M, Simone G. Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):465-471. doi: 10.1016/j.euf.2021.03.002. Epub 2021 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized study is designed to provide high level of evidence supporting superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially linked to a reduced invasiveness are considered as secondary endpoints. Investigators hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and to faster return to daily activities. These data will be taken into account in a matched cost analysis between arms. Secondary aims include a between arm matched comparison of perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and nighttime continence).', 'detailedDescription': "Despite encouraging data deriving from colorectal surgery, evidences in favor to ERAS protocols following RARC are poor. Moreover, according to a recent survey of surgeons with a specialist interest in RC, the adherence to ERAS protocols is \\<20% \\[1\\].\n\nRetrospective and preliminary data from the robotic consortium have supported oncologic effectiveness of RARC; however in the only prospective randomized trial comparing RARC and ORC urinary diversions were performed extracorporeally, potentially impairing the benefits of minimally invasive surgery \\[2\\].\n\nRobot assisted radical cystectomy (RARC) has the aim of providing adequate cancer control while minimizing invasiveness of open radical cystectomy (ORC). The primary end-point of this trial is to demonstrate a reduction of perioperative transfusion rate in RARC arm by 50% compared to ORC arm.\n\nERAS protocols may significantly contribute to shortening length of hospital stay, a key outcome in this clinical setting of patients receiving RC, being the mean length of hospital stay around 14 days in Italy. Investigators' hypothesis is that the reduced invasiveness of RARC might contribute to an increased adoption of ERAS protocols (reduced need for reinsertion of nasogastric tube, shorter time to first flatus, to mobilization, to regular diet and finally shorter duration of hospital stay).\n\nAssessment of oncologic outcomes of RARC, although not the primary endpoint of the present study, is certainly an outcome of interest. The expected duration of enrollment (18 mo) should provide 2-yr oncologic outcomes for about 66% of patients. Two-year recurrence free survival has been reported as a valid surrogate marker of long term oncologic survival after RC.\n\nSpecific Aim 1:To demonstrate superiority of RARC versus ORC in terms of 50% reduction of perioperative transfusion rates.\n\nSpecific Aim 2:\n\nTo evaluate invasiveness of both surgical approaches by assessing the adherence to ERAS protocols in both and the incidence of perioperative and 30-d, 90d, 180d complications, readmission rates (30d, 90d). Cost analysis will assess the potential impact of shorter hospital stay on overall costs of robotic procedures.\n\nSpecific Aim 3:\n\nTo assess quality of life at 6-mo, 12-mo and 24-mo follow-up evaluation and to perform a matched comparison of oncologic and functional outcomes between two arms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.\n\nExclusion Criteria:\n\n* Cystectomy without curative intent (palliative, salvage).\n* Patients unfit for robotic cystectomy.'}, 'identificationModule': {'nctId': 'NCT03434132', 'briefTitle': 'Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'GR2016-02364306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open Radical Cystectomy', 'description': 'Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit)', 'interventionNames': ['Procedure: Open or robotic radical cystectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Robot assisted radical cystectomy', 'description': 'Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit)', 'interventionNames': ['Procedure: Open or robotic radical cystectomy']}], 'interventions': [{'name': 'Open or robotic radical cystectomy', 'type': 'PROCEDURE', 'description': "ORC and orthotopic ileal neobladder is performed as previously described. A separate package PLND is performed as in open as in robotic surgery. RARC is performed replicating open surgical procedure.\n\nThe orthotopic ileal neobladder model used is the 'vescica ileale padovana' as previously described. An ileal segment, approximately 42 cm long, is chosen at a minimum distance of 20cm far from ileo-cecal valve. A latero-lateral ileal anastomosis is performed with staplers to restore bowel continuity.\n\nFor ileal conduit, a 20cm ileal segment (approximately 20 cm long) at a minimum distance of 20 cm from ileo-cecal valve is isolated and transected with staplers. Bowel continuity is restored as previously described. The ileal loop on its distal edge is extracted through abdomen wall at the previously identified stoma point and fixed to abdomen fascia. The ureters are spatulated and a latero-lateral anastomosis according to Wallace 1 technique is performed.", 'armGroupLabels': ['Open Radical Cystectomy', 'Robot assisted radical cystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Regina Elena NCI', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Giuseppe Simone, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Regina Elena" National Cancer Institute, Dept of Urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministero della Salute, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, COnsultant Urologist', 'investigatorFullName': 'Giuseppe SImone', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}