Study Design and Inclusion Criteria
The Italian Radical Cystectomy Registry (RIC) is an observational, prospective, multicenter, cohort study, assessing patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion via open, laparoscopic, or robotic-assisted technique (23). Both male and female consecutive patients are enrolled. Additionally, patients must be ≥18 years old and have histologically confirmed diagnosis of bladder cancer eligible for radical cystectomy surgery (according to EAU guidelines) at enrollment. Enrollment was planned to occur from January 1st 2017 to June 30th 2020, with a goal of enrolling 1000 patients, based on power calculations.
RIC is an electronic registry, and data is collected from patients at one of the 28 participating clinical centers (Table 1). At each center, patient data is collected in accordance with Italian privacy laws, and entered into an online database by a coordinating physician. Data collection and entering was done using the Data Collection Form, which was designed by the Scientific and Steering Committees. The Data collection form was designed using either pre-specified or open-ended responses for each question, to ensure homogeneity between centers.
Patient data are securely stored and kept anonymous using identification codes. The database is password protected. As data sharing is becoming increasingly important, the data is regularly transferred to a globally-accessible online platform. The trial has been registered retrospectively on ClinicalTrials.gov on 14/01/2020 with reference number NCT04228198. Data collection is conducted in accordance with the World Medical AssociationDeclaration of Helsinki. This study was approved on 25/06/2020 by Ethical Committee of the University of Padova (number: 0042389). All patients provide signed, informed consent.
Participating Centers
All clinics and hospitals in Italy that currently provide care for radical cystectomy patients using all three (open, robotic, laparoscopic) techniques included in this study were invited to participate. Participation was done on a voluntary basis, without additional funding for the centers or participants. A physician at each center was assigned the role of managing patient recruitment, data collection, and the entering of the data into the registry, including maintaining data security and anonymity of the patients. Patients were enrolled at 28 centers across Italy: Urology Clinic, University of Bologna; Department of Urology, AOU Careggi, Florence; European Institute of Oncology Milan; San Raffaele Hospital, Milan; University Hospital of Verona; Department of Urology, Policlinico Abano Terme (PD); Department of Urology, Spedali Civili, Brescia; Department of Urology and Kidney Transplantation, University of Foggia, Foggia; Galliera Hospital, Genoa; ASST Niguarda Metropolitan Hospital, Milan; Policlinico Umberto I, Sapienza Rome University, Rome; Department of Clinical Urology, University of Perugia; Department of Clinical Urology, Pisa; Department of Clinical Urology, Palermo University, Palermo; Department of Clinical Urology, Alessandria Hospital, Alessandria; Department of Clinical Urology, ASST Mantova, Mantova; Department of Clinical Urology, ASL Abruzzo, Chieti; Department of Clinical Urology Ca Foncello Hospital, Treviso; Department of Clinical Urology II, Bari University, Bari; Department of Clinical Urology, Vittorio Emanuele Hospital, Catania; Department of Clinical Urology, Casa Sollievo della Sofferenza, San Giovanni Rotondo; Hospital Bassiano, Bassano del Grappa; Department of Clinical Urology, Hospital San Francesco ASL 3, Nuoro; Department of Clinical Urology, Portogruaro; Department of Clinical Urology, Biella Hospital, Biella; Department of Clinical Urology Chioggia Hospital; Ausl Modena, Modena; Department of Urology and Kidney Transplantation, Bianchi-Melacrino-Morelli Grand Metropolitan Hospital, Reggio Calabria (Table 1).
Timeline and data collection
Patient enrollment was planned for January 1st 2017 to June 30th 2020 (Figure 1). At each center, preoperative tumor staging, grading, ASA score, comorbidities, Charlson Comorbidity Index (CCI), concomitant CIS, chemotherapy use, BCG instillation, palliative cystectomy, and patient characteristics (age, sex, etc.) were collected preoperatively. Patients were operated on using laparoscopic, robotic or open surgery technique, at the discretion of the surgeon. Postoperatively, surgery time, type of urinary diversion, conversion to open surgery, presence of bleeding, nerve sparing, and lymphadenectomy were collected. Finally, follow-up care, histology (e.g., postoperative staging and grading), short-term (<30 days) (e.g., complications, readmissions, mortality), and long-term (≥24 months) (e.g., mortality, survival, sexual potency, continence) parameter were collected.
Statistical Analysis
Data were cleaned and checked for discrepancies by a statistician before analysis and dissemination. In the case of missing data, the physician from the respective center was contacted and asked to review medical records and data sheets for the missing information, to minimize missingness. Chi-square and t-tests were used to compare categorical and continuous variables, respectively, between surgical technique groups. Statistical analyses were performed using Stata-SE 15 (StataCorp LP, College Station, TX, USA). All tests were 2-sided with a significance level set at p<0.05.