Protocol of the Italian Radical Cystectomy Registry

Protocol of the Italian Radical Cystectomy Registry: a Non-randomized, 24-month, Multicenter Study Comparing Robotic-assisted, Laparoscopic, and Open Surgery for Radical Cystectomy in Bladder Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Radical cystectomy

Detailed Description

The aim of the 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.

Twenty-eight participating centers across Italy will provide data for the study: 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; Department of Urology, Spedali Civili, Brescia; Department of Urology and Kidney Transplantation, University of Foggia, Foggia; Galliera Hospital, Genova; ASST Niguarda Metropolitan Hospital, Niguarda; Policlinico Umberto I, Saproma; Department of Clinical Urology, University of Perugia; Department of Clinical Urology, AOUP Cisanello Hospital, 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; 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, Sgrotondo; Hospital Bassiano, Bassano; 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; Department of Urology and Kidney Transplantation, Bianchi-Melacrino-Morelli Grand Metropolitan Hospital.

The inclusion criteria are: 1) male and female consecutively recruited patients; 2) age ≥18 years; 3) histologically confirmed diagnosis of bladder cancer eligible for radical cystectomy surgery at date of enrollment; 4) providing written, informed consent.

At baseline and after 3, 6, 12, and 24 months post-surgery, data will be taken directly from the patients at their follow-up medical visits and entered into the online database. The physician identifying and recruiting patients is in charge of completing the data collection forms during follow-up, even if the patient is subsequently treated in another center.

Variables of interest include demographic variables (age, sex, etc), surgical factors (technique use, length of surgery, blood loss, type of urinary diversion, node burden, histological exams, surgical margins etc), mortality, morbidity (pre-, during- and post-surgery), oncological results, and functioning (continence and sexual performance) over follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Recruiting
    • policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
    • Contact: Ettore De Berardinis, Professor; Phone Number: +393355374223; Email: ettore.deberardinis@uniroma1.it
    • Principal Investigator: Ettore De Berardinis, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population is composed of subjects affected by bladder cancer that will undergo radical cystectomy. Surgery has been than divided in three different approaches: laparoscopic, robot-assisted and open.

Description

Inclusion Criteria:

• Male and female consecutively recruited patients
• Age ≥18 years
• Histologically confirmed diagnosis of bladder cancer eligible for radical cystectomy surgery (according to EAU guidelines) at date of enrollment
• Providing written, informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radical cystectomy; Patients with histologically confirmed diagnosis of bladder cancer undergoing radical cystectomy surgery at 28 Urology departments in Italy	Procedure: Radical cystectomy; Procedure/Surgery: Radical cystectomy. Removal of urinary bladder with three different approaches: i) Robotic-assisted, ii) Laparoscopic, and iii) Open Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery time	Total surgery time, in minutes during surgery at baseline	Baseline
Type of urinary diversion	Type of urinary diversion performed during the cystectomy surgery at baseline	Baseline
Eventual conversion to open surgery	If the surgery technique changes from laproscopic surgery to open surgery during the intervention at baseline	Baseline
Amount of surgical blood loss	Amount of blood lost during the surgical procedure at baseline in milliliters	Baseline
Number of participants who underwent nerve-sparing	Nerve sparing during baseline surgery (no/unilateral/bilateral)	Baseline
Number of participants who underwent lymphadenectomy	lymphadenectomy (not performed/ bilateral external iliac nodes /bilateral presacral iliac) during baseline surgery	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological evaluation of all patients	Tumor histology, (transitional cell carcinoma, adenocarcinoma, or other)	Immediately after surgery
Rate of Mortality	All-cause mortality after surgery	Up to 24 months
Rate of Hospitalization	Any in-patient hospitalization in teh 24 months following surgical discharge.	Up to 24 months
Sexual potency rates	Sexual potency in the patient following surgery. Self-reported.	Up to 24 months
Continence rates	Daytime and nighttime continence following surgery.	Up to 24 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• Porreca A, Palmer K, Artibani W, Antonelli A, Bianchi L, Brunocilla E, Bocciardi AM, Brausi M, Busetto GM, Carini M, Carrieri G, Celia A, Cindolo L, Cochetti G, Colombo R, De Berardinis E, De Cobelli O, Di Maida F, Ercolino A, Gaboardi F, Galfano A, Gallina A, Gallucci M, Introini C, Mearini E, Minervini A, Montorsi F, Musi G, Pini G, Schiavina R, Secco S, Serni S, Simeone C, Tasso G, D'Agostino D. 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. BMC Cancer. 2021 Jan 11;21(1):51. doi: 10.1186/s12885-020-07748-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 11, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 11, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: R.I.C.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No