Bladder CancerNCT04900558
Robotic Radical Cystectomy Outcomes
An observational study of Bladder Cancer and Muscle-Invasive Bladder Carcinoma, run by University of Florence at 1 site in Italy.
Trial summary
Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Oncology
- What is being tested?
- Radical Cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2021to 1 Feb 2038
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population is made up of patients who underwent radical cystectomy at AOU Careggi, SOD Robotic Urological Surgery, Minimally Invasive and Renal Transplantation.
Who may be able to join
- Age major or equal 18 years
- Patients who will undergo radical cystectomy
- Consent to participate
Who cannot join
- Absence of willingness to participate
- Further refusal to participate to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Silvia Benemei, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Careggi University Hospital
Florence, Tuscany, 50134
Simone Morselli, MD, 3473050852, simone.morselli@unifi.it
Arcangelo Sebastianelli, MD, arcangelo.sebastianelli@gmail.com
About this study
Official title: Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy
Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery
- Conditions
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Oncology, Recurrence, Surgery
- Being tested
- Radical Cystectomy
- Keywords
- Cystectomy, Radical Cystectomy, Ileal Conduit, Neobladder, Bladder Cancer, Muscle Invasive Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical CystectomyProcedure or surgery
All the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc...
| Study group | Role | What they receive |
|---|---|---|
| Radical Cystectomy | Patients who underwent radical cystectomy for bladder cancer in our centre Receives: Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will die from bladder cancer
Bladder Cancer Specific Mortality after surgery
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence
Bladder Cancer Recurrence
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will die from all causes
All cause mortality after surgery
Measured: From enrollment to late follow-up, up to 7 years
Secondary outcomes (9)
Number of participants who will die from bladder cancer after Robotic Surgery
Robotic surgery specific impact on survival
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence after Robotic Surgery
Robotic surgery specific impact on recurrence
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will experience surgical complications after Robotic Surgery
Robotic surgery specific impact on surgical complications
Measured: From enrollment to late follow-up, up to 7 years
Variation in Quality of Life questionnaire after Robotic Surgery
Robotic surgery specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Measured: From enrollment to late follow-up, up to 7 years
Variation in Quality of Life questionnaire according to Urinary diversions
Urinary diversion specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will experience surgical complications according to Urinary diversions
Urinary diversion specific impact on surgical complications
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence according to Urinary diversions
Urinary diversion specific impact on bladder cancer recurrence
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will die from bladder cancer according to Urinary diversions
Urinary diversion specific impact on bladder cancer rmortality
Measured: From enrollment to late follow-up, up to 7 years
Number of participants who will die from all causes according to Urinary diversions
Urinary diversion specific impact on all cause mortality after surgery
Measured: From enrollment to late follow-up, up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start29 Apr 2021
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Principal investigator, Simone Morselli, University of Florence
- Investigators
- Arcangelo Sebastianelli, MD, Principal investigator, Careggi Hospital, University of FlorenceSergio Serni, Prof, Principal investigator, University of FlorenceSimone Morselli, MD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900558
- Sponsor's protocol ID
- 19303_oss
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04900558
- Acronym / sponsor ID
- 19303_oss
- Conditions
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Oncology, Recurrence, Surgery
- Keywords
- Cystectomy, Radical Cystectomy, Ileal Conduit, Neobladder, Bladder Cancer, Muscle Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2038 (estimated)
- First posted
- 25 May 2021 (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.
Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical Cystectomy | – | Procedure: Radical CystectomyPatients who underwent radical cystectomy for bladder cancer in our centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is made up of patients who underwent radical cystectomy at AOU Careggi, SOD Robotic Urological Surgery, Minimally Invasive and Renal Transplantation.
Key inclusion criteria (3 listed)
- Age major or equal 18 years
- Patients who will undergo radical cystectomy
- Consent to participate
Key exclusion criteria (2 listed)
- Absence of willingness to participate
- Further refusal to participate to the study
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 CystectomyAll the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc... | Procedure or surgery | Radical Cystectomy |
Primary outcome
Number of participants who will die from bladder cancer
Time frame: From enrollment to late follow-up, up to 7 years
Bladder Cancer Specific Mortality after surgery
Number of participants who will experience bladder cancer recurrence
Time frame: From enrollment to late follow-up, up to 7 years
Bladder Cancer Recurrence
Number of participants who will die from all causes
Time frame: From enrollment to late follow-up, up to 7 years
All cause mortality after surgery
9 secondary outcomes
Number of participants who will die from bladder cancer after Robotic Surgery
Time frame: From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence after Robotic Surgery
Time frame: From enrollment to late follow-up, up to 7 years
Number of participants who will experience surgical complications after Robotic Surgery
Time frame: From enrollment to late follow-up, up to 7 years
Variation in Quality of Life questionnaire after Robotic Surgery
Time frame: From enrollment to late follow-up, up to 7 years
Variation in Quality of Life questionnaire according to Urinary diversions
Time frame: From enrollment to late follow-up, up to 7 years
Number of participants who will experience surgical complications according to Urinary diversions
Time frame: From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence according to Urinary diversions
Time frame: From enrollment to late follow-up, up to 7 years
Number of participants who will die from bladder cancer according to Urinary diversions
Time frame: From enrollment to late follow-up, up to 7 years
Number of participants who will die from all causes according to Urinary diversions
Time frame: From enrollment to late follow-up, up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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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.
Silvia Benemei, PhD contact
Arcangelo Sebastianelli, MD principal investigator
Careggi Hospital, University of Florence
Sergio Serni, Prof principal investigator
University of Florence
Simone Morselli, MD principal investigator
University of Florence
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 and Muscle-Invasive Bladder Carcinoma, run by University of Florence 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 May 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Morselli, MD (3473050852, simone.morselli.89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who will die from bladder cancer (time frame: From enrollment to late follow-up, up to 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2021.