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
NCT number | NCT04228198 |
Other study ID # | R.I.C. |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | June 30, 2020 |
Verified date | January 2020 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 30, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgery time | Total surgery time, in minutes during surgery at baseline | Baseline | |
Primary | Type of urinary diversion | Type of urinary diversion performed during the cystectomy surgery at baseline | Baseline | |
Primary | Eventual conversion to open surgery | If the surgery technique changes from laproscopic surgery to open surgery during the intervention at baseline | Baseline | |
Primary | Amount of surgical blood loss | Amount of blood lost during the surgical procedure at baseline in milliliters | Baseline | |
Primary | Number of participants who underwent nerve-sparing | Nerve sparing during baseline surgery (no/unilateral/bilateral) | Baseline | |
Primary | Number of participants who underwent lymphadenectomy | lymphadenectomy (not performed/ bilateral external iliac nodes /bilateral presacral iliac) during baseline surgery | Baseline | |
Secondary | Histological evaluation of all patients | Tumor histology, (transitional cell carcinoma, adenocarcinoma, or other) | Immediately after surgery | |
Secondary | Rate of Mortality | All-cause mortality after surgery | Up to 24 months | |
Secondary | Rate of Hospitalization | Any in-patient hospitalization in teh 24 months following surgical discharge. | Up to 24 months | |
Secondary | Sexual potency rates | Sexual potency in the patient following surgery. Self-reported. | Up to 24 months | |
Secondary | Continence rates | Daytime and nighttime continence following surgery. | Up to 24 months |
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