Clinical trial NCT04900558: Robotic Radical Cystectomy Outcomes
Official title: Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Oncology
Recurrence
Surgery
Keywords: Cystectomy
Radical Cystectomy
Ileal Conduit
Neobladder
Bladder Cancer
Muscle Invasive Bladder Cancer
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2021-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

* Age major or equal 18 years
* Patients who will undergo radical cystectomy
* Consent to participate

Exclusion Criteria:

* Absence of willingness to participate
* Further refusal to participate to the study

Primary outcomes:
measure: Number of participants who will die from bladder cancer
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will experience bladder cancer recurrence
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will die from all causes
timeFrame: From enrollment to late follow-up, up to 7 years
Secondary outcomes:
measure: Number of participants who will die from bladder cancer after Robotic Surgery
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will experience bladder cancer recurrence after Robotic Surgery
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will experience surgical complications after Robotic Surgery
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Variation in Quality of Life questionnaire after Robotic Surgery
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Variation in Quality of Life questionnaire according to Urinary diversions
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will experience surgical complications according to Urinary diversions
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will experience bladder cancer recurrence according to Urinary diversions
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will die from bladder cancer according to Urinary diversions
timeFrame: From enrollment to late follow-up, up to 7 years
measure: Number of participants who will die from all causes according to Urinary diversions
timeFrame: From enrollment to late follow-up, up to 7 years
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi University Hospital
state: Tuscany
Study officials:
affiliation: Careggi Hospital, University of Florence
name: Arcangelo Sebastianelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Sergio Serni, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Simone Morselli, MD
role: PRINCIPAL_INVESTIGATOR
References: