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Protocol of the Italian Radical Cystectomy Registry

NCT04228198 · University of Roma La Sapienza · Updated 14 Jan 2020

What is being tested
Radical cystectomy
For
Bladder Cancer
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 1,000 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 1 Jan 2017, ends 30 June 2020. Registered 14 Jan 2020.
Results
None posted yet.

In the researchers' words

Background: Bladder cancer is the ninth most common type of cancer worldwide. In the past, Radical Cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy surgery. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy surgery comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence. Methods: The study is an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing Radical Cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with recruitment phase between 1st January 2017-31st June 2020). Information is…
ClinicalTrials.gov, NCT04228198

Sites

  • policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological SciencesRoma, Italy