Protocol of the Italian Radical Cystectomy Registry

NCT04228198 | Unknown

• 1 other identifier: R.I.C.
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Histological evaluation of all patients

  Immediately after surgery

• Rate of Mortality

  Up to 24 months

• Rate of Hospitalization

  Up to 24 months

• Sexual potency rates

  Up to 24 months

• Continence rates

  Up to 24 months

Study Arms (1)

Radical cystectomy

Patients with histologically confirmed diagnosis of bladder cancer undergoing radical cystectomy surgery at 28 Urology departments in Italy

Procedure: Radical cystectomy

Interventions

Radical cystectomy PROCEDURE

Procedure/Surgery: Radical cystectomy. Removal of urinary bladder with three different approaches: i) Robotic-assisted, ii) Laparoscopic, and iii) Open Surgery

Radical cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Roma, 00161, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 33430820 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 14, 2020
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: June 30, 2020
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)