NCT04228198

Protocol of the Italian Radical Cystectomy Registry

Status unknown Last updated 14 January 2020

What this trial tests

trial testing Radical cystectomy in Bladder Cancer in 1,000 participants. Status unknown.

Timeline

1 January 2017

Primary endpoint
1 January 2020

30 June 2020

Quick facts

Lead sponsor	University of Roma La Sapienza
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 January 2017
Primary completion	1 January 2020
Estimated completion	30 June 2020
Sites	1 location across Italy

Drugs / interventions tested

• Radical cystectomy

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

University of Roma La Sapienza

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy surgery). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerves sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc).

Discussion: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Robotic-assisted, laparoscopic, and open radical cystectomy: surgical data of 1400 patients from The Italian Radical Cystectomy Registry on intraoperative outcomes.
   Porreca A, Di Gianfrancesco L, Artibani W, Busetto GM, et al · · 2022 · cited 9× · PMID 35937656 · DOI 10.5173/ceju.2022.0284
2. Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer.
   Porreca A, Palmer K, Artibani W, Antonelli A, et al · · 2021 · cited 8× · PMID 33430820 · DOI 10.1186/s12885-020-07748-7
3. Robot-Assisted, Laparoscopic, and Open Radical Cystectomy: Pre-Operative Data of 1400 Patients From The Italian Radical Cystectomy Registry.
   Busetto GM, D'Agostino D, Colicchia M, Palmer K, et al · · 2022 · cited 7× · PMID 35600337 · DOI 10.3389/fonc.2022.895460
4. Robot-Assisted Radical Cystectomy with Ureterocutaneostomy: A Potentially Optimal Solution for Octogenarian and Frail Patients with Bladder Cancer.
   Porreca A, Marino F, De Marchi D, Crestani A, et al · · 2025 · cited 1× · PMID 40725592 · DOI 10.3390/jcm14144898