Robotic Radical Cystectomy Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florence
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age major or equal 18 years
Patients who will undergo radical cystectomy
Consent to participate
Disqualifiers
Absence of willingness to participate
Further refusal to participate to the study
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Radical Cystectomy
Procedure/SurgeryAll 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...
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Radical Cystectomy1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who will die from bladder cancer
Bladder Cancer Specific Mortality after surgery
Time frame
From enrollment to late follow-up, up to 7 years2
Number of participants who will experience bladder cancer recurrence
Bladder Cancer Recurrence
Time frame
From enrollment to late follow-up, up to 7 years3
Number of participants who will die from all causes
All cause mortality after surgery
Time frame
From enrollment to late follow-up, up to 7 yearsSecondary outcomes
1
Number of participants who will die from bladder cancer after Robotic Surgery
Robotic surgery specific impact on survival
Time frame
From enrollment to late follow-up, up to 7 years2
Number of participants who will experience bladder cancer recurrence after Robotic Surgery
Robotic surgery specific impact on recurrence
Time frame
From enrollment to late follow-up, up to 7 years3
Number of participants who will experience surgical complications after Robotic Surgery
Robotic surgery specific impact on surgical complications
Time frame
From enrollment to late follow-up, up to 7 years4
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)
Time frame
From enrollment to late follow-up, up to 7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florence
Lead sponsor
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Source ClinicalTrials.gov