Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-23 @ 1:14 PM
Study NCT ID:
NCT02665156
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)', 'timeFrame': '1 yr'}], 'secondaryOutcomes': [{'measure': 'Perioperative complications', 'timeFrame': '6 months', 'description': 'Assessment of perioperative complications 30 days, 90 days and 180 days after surgery'}, {'measure': 'Readmission rate', 'timeFrame': '6 months', 'description': 'Incidence of readmission'}, {'measure': 'Neobladder stone formation', 'timeFrame': '1-yr', 'description': 'Incidence of neobladder stone formation'}, {'measure': 'Cost analysis', 'timeFrame': '1-yr'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystectomy', 'Robotic Surgical Procedures', 'Surgical Staplers']}, 'descriptionModule': {'briefSummary': 'Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic neobladder should be 5 hours in high volume centers .\n\nThis prospective single-stage phase 2 trial is designed to assess the time efficiency of using robotic stapler versus the conventional motorized staplers (Linear stapler articulated Endo GIA™, Covidien) in achieving the target outcome (total operative time \\<5 hr).\n\nPerioperative complications (intraoperative and 30-d postoperative complications according to the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates, early functional outcomes (time to recovery of urinary continence), 180-d and 360-d neobladder stone formation rates will be analyzed to assess the safety and the cost effectiveness of the procedure.', 'detailedDescription': "The primary end point by which the sample size was determined was a total operative time \\<5hr. In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers maintaining the total operative time of the procedure \\<5hrs in at least 80% (p1) of cases. According to A'Hern, in order to verify the significance of this hypothesis, the estimated sample size is 33 patients with a power of 80% at a significance level of 5%. The trial will be successful if the total operative time will be \\<5hrs in at least 25 out of 33 patients.\n\nThe population of this study will include 35 patients with muscle invasive bladder cancer without contraindications to orthotopic neobladder. The first two cases will be excluded in order to provide the entire surgical team the minimal skill necessary for a proper and time efficient use of the new surgical device (robotic stapler). The following 33 consecutive cases will be enrolled and the outcomes analyzed. The estimated time to complete the enrollment is 9 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pathologically confirmed muscle invasive bladder cancer or recurrent high grade urothelial carcinoma (BCG failures)\n\nExclusion Criteria:\n\n* All absoulte contraindications to orthotopic neobladder;\n* Anesthesiologic contraindications to penumoeperitoneum and steep Trendelenburg position.\n* cT4 disease;\n* clinical evidence of metastases (cM1) outside the pelvis.'}, 'identificationModule': {'nctId': 'NCT02665156', 'briefTitle': 'Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Phase 2 Clinical Trial to Assess Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy', 'orgStudyIdInfo': {'id': '1034/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic Stapled orthotopic neobladder', 'description': 'Intracorporeal stapled neobladder using robotic staplers: Partly stapled orthotopic neobladder: robotic staplers applied to create the neobladder neck and to suture the left side of the posterior aspect of neobladder. Right side of the posterior aspect of neobladder and the anterior aspect of the neobladder hand sewn.', 'interventionNames': ['Procedure: Intracorporeal stapled neobladder using robotic staplers']}], 'interventions': [{'name': 'Intracorporeal stapled neobladder using robotic staplers', 'type': 'PROCEDURE', 'description': 'Robot assisted radical cystecomy. Separate packages extended pelvic lymph node dissection up to aortic bifurcation. Totally intracorporeal orthotopic ileal neobladder with about 45 cm of ileum according to "Vescica Ileal Padovana".', 'armGroupLabels': ['Robotic Stapled orthotopic neobladder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': '"Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Giuseppe Simone, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Regina Elena" National Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Giuseppe SImone', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}