Bladder CancerNCT04228198
Protocol of the Italian Radical Cystectomy Registry
An observational study of Bladder Cancer, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Radical cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
Roma, 00161
Ettore De Berardinis, Professor, +393355374223, ettore.deberardinis@uniroma1.it
Ettore De Berardinis, Professor
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical cystectomyProcedure or surgery
Procedure/Surgery: Radical cystectomy. Removal of urinary bladder with three different approaches: i) Robotic-assisted, ii) Laparoscopic, and iii) Open Surgery
| Study group | Role | What they receive |
|---|---|---|
| Radical cystectomy | Patients with histologically confirmed diagnosis of bladder cancer undergoing radical cystectomy surgery at 28 Urology departments in Italy Receives: Procedure: Radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery time
Total surgery time, in minutes during surgery at baseline
Measured: Baseline
Type of urinary diversion
Type of urinary diversion performed during the cystectomy surgery at baseline
Measured: Baseline
Eventual conversion to open surgery
If the surgery technique changes from laproscopic surgery to open surgery during the intervention at baseline
Measured: Baseline
Amount of surgical blood loss
Amount of blood lost during the surgical procedure at baseline in milliliters
Measured: Baseline
Number of participants who underwent nerve-sparing
Nerve sparing during baseline surgery (no/unilateral/bilateral)
Measured: Baseline
Number of participants who underwent lymphadenectomy
lymphadenectomy (not performed/ bilateral external iliac nodes /bilateral presacral iliac) during baseline surgery
Measured: Baseline
Secondary outcomes (5)
Histological evaluation of all patients
Tumor histology, (transitional cell carcinoma, adenocarcinoma, or other)
Measured: Immediately after surgery
Rate of Mortality
All-cause mortality after surgery
Measured: Up to 24 months
Rate of Hospitalization
Any in-patient hospitalization in teh 24 months following surgical discharge.
Measured: Up to 24 months
Sexual potency rates
Sexual potency in the patient following surgery. Self-reported.
Measured: Up to 24 months
Continence rates
Daytime and nighttime continence following surgery.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore De Berardinis, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228198
- Sponsor's protocol ID
- R.I.C.
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33430820
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04228198
- Acronym / sponsor ID
- R.I.C.
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical cystectomy | – | Procedure: Radical cystectomyPatients with histologically confirmed diagnosis of bladder cancer undergoing radical cystectomy surgery at 28 Urology departments in Italy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical cystectomyProcedure/Surgery: Radical cystectomy. Removal of urinary bladder with three different approaches: i) Robotic-assisted, ii) Laparoscopic, and iii) Open Surgery | Procedure or surgery | Radical cystectomy |
Primary outcome
Surgery time
Time frame: Baseline
Total surgery time, in minutes during surgery at baseline
Type of urinary diversion
Time frame: Baseline
Type of urinary diversion performed during the cystectomy surgery at baseline
Eventual conversion to open surgery
Time frame: Baseline
If the surgery technique changes from laproscopic surgery to open surgery during the intervention at baseline
Amount of surgical blood loss
Time frame: Baseline
Amount of blood lost during the surgical procedure at baseline in milliliters
Number of participants who underwent nerve-sparing
Time frame: Baseline
Nerve sparing during baseline surgery (no/unilateral/bilateral)
Number of participants who underwent lymphadenectomy
Time frame: Baseline
lymphadenectomy (not performed/ bilateral external iliac nodes /bilateral presacral iliac) during baseline surgery
5 secondary outcomes
Histological evaluation of all patients
Time frame: Immediately after surgery
Rate of Mortality
Time frame: Up to 24 months
Rate of Hospitalization
Time frame: Up to 24 months
Sexual potency rates
Time frame: Up to 24 months
Continence rates
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 33430820Porreca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery time (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.