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

Angelo Porreca, Katie Palmer, Walter Artibani, Alessandro Antonelli, Lorenzo Bianchi, Eugenio Brunocilla, Aldo Massimo Bocciardi, Maurizio Brausi, Gian Maria Busetto, Marco Carini, Giuseppe Carrieri, Antonio Celia, Luca Cindolo, Giovanni Cochetti, Renzo Colombo, Ettore De Berardinis, Ottavio De Cobelli, Fabrizio Di Maida, Amelio Ercolino, Franco GaboardiAntonio Galfano, Andrea Gallina, Michele Gallucci, Carlo Introini, Ettore Mearini, Andrea Minervini, Francesco Montorsi, Gennaro Musi, Giovannalberto Pini, Riccardo Schiavina, Silvia Secco, Sergio Serni, Claudio Simeone, Giovanni Tasso, Daniele D’Agostino

Research output: Contribution to journalArticlepeer-review

Abstract

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. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy 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: We describe a protocol for 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 the recruitment phase between 1st January 2017-31st October 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). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve 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. Trial registration: ClinicalTrials.gov, NCT04228198. Registered 14th January 2020- Retrospectively registered.

Original languageEnglish
Article number51
JournalBMC Cancer
Volume21
Issue number1
DOIs
Publication statusPublished - Dec 2021

Keywords

  • Bladder reconstruction
  • Cancer
  • Neoplasm; bladder
  • Prostate
  • Robotic
  • Surgery
  • Urinary

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this