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Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.

NCT03434132 · Regina Elena Cancer Institute · Updated 19 Jan 2023

What is being tested
Open or robotic radical cystectomy
For
Bladder Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 116 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 29 Jan 2018, ends 30 Sept 2022. Registered 15 Feb 2018.
Results
None posted yet.

In the researchers' words

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).
ClinicalTrials.gov, NCT03434132

Sites

  • Regina Elena NCIRome, Lazio, Italy