Status:
COMPLETED
Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.
Lead Sponsor:
Regina Elena Cancer Institute
Collaborating Sponsors:
Ministero della Salute, Italy
Conditions:
Bladder Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
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% red...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.
Exclusion
- Cystectomy without curative intent (palliative, salvage).
- Patients unfit for robotic cystectomy.
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03434132
Start Date
January 29 2018
End Date
September 30 2022
Last Update
January 19 2023
Active Locations (1)
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1
Regina Elena NCI
Rome, Lazio, Italy, 00144