Bladder Cancer Clinical Trial
Official title:
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.
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.
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