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 Gaboardi,
Antonio 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
Affiliations
Angelo Porreca
Istituto Oncologico Veneto IRCCS
Katie Palmer
Department of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore
Walter Artibani
Department of Urology, Policlinico Abano Terme
Alessandro Antonelli
Department of Urology, Azienda Ospedaliera Universitaria Integrata (A.O.U.I.)
Lorenzo Bianchi
Department of Urology, University of Bologna
Eugenio Brunocilla
Department of Urology, University of Bologna
Aldo Massimo Bocciardi
Struttura Complessa Urologia, ASST, Grande Ospedale Metropolitano Niguarda
Maurizio Brausi
Divisione Urologia AUSL
Gian Maria Busetto
Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital
Marco Carini
Department of Urology, Careggi Hospital, University of Florence
Giuseppe Carrieri
Urology and Renal Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia
Antonio Celia
Department of Urology, San Bassiano Hospital
Luca Cindolo
Department of Urology, “Villa Stuart” Private Hospital
Giovanni Cochetti
Department of Urology, University of Perugia
Renzo Colombo
Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute
Ettore De Berardinis
Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital
Ottavio De Cobelli
IEO European Institute of Oncology, IRCCS
Fabrizio Di Maida
Department of Urology, Careggi Hospital, University of Florence
Amelio Ercolino
Department of Urology, University of Bologna
Franco Gaboardi
Department of Urology, San Raffaele Turro Hospital
Antonio Galfano
Divisione Urologia AUSL
Andrea Gallina
Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute
Michele Gallucci
Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital
Carlo Introini
Department of Urology, E.O. Ospedali Galliera
Ettore Mearini
Department of Urology, University of Perugia
Andrea Minervini
Department of Urology, Careggi Hospital, University of Florence
Francesco Montorsi
Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute
Gennaro Musi
IEO European Institute of Oncology, IRCCS
Giovannalberto Pini
Department of Urology, San Raffaele Turro Hospital
Riccardo Schiavina
Department of Urology, University of Bologna
Silvia Secco
Struttura Complessa Urologia, ASST, Grande Ospedale Metropolitano Niguarda
Sergio Serni
Department of Urology, Careggi Hospital, University of Florence
Claudio Simeone
Department of Urology, University of Brescia
Giovanni Tasso
Department of Urology, Careggi Hospital, University of Florence
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.
