Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Oncology, Recurrence, Surgery
Conditions
Keywords
Cystectomy, Radical Cystectomy, Ileal Conduit, Neobladder, Bladder Cancer, Muscle Invasive Bladder Cancer
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
Interventions
PROCEDURERadical Cystectomy
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...
Sponsors
Azienda Ospedaliero-Universitaria Careggi
University of Florence
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who will die from bladder cancer | 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 | From enrollment to late follow-up, up to 7 years | Bladder Cancer Recurrence |
| Number of participants who will die from all causes | From enrollment to late follow-up, up to 7 years | All cause mortality after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in Quality of Life questionnaire after Robotic Surgery | From enrollment to late follow-up, up to 7 years | 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) |
| Variation in Quality of Life questionnaire according to Urinary diversions | From enrollment to late follow-up, up to 7 years | 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) |
| Number of participants who will experience surgical complications according to Urinary diversions | From enrollment to late follow-up, up to 7 years | Urinary diversion specific impact on surgical complications |
| Number of participants who will die from bladder cancer after Robotic Surgery | From enrollment to late follow-up, up to 7 years | Robotic surgery specific impact on survival |
| Number of participants who will die from bladder cancer according to Urinary diversions | From enrollment to late follow-up, up to 7 years | Urinary diversion specific impact on bladder cancer rmortality |
| Number of participants who will die from all causes according to Urinary diversions | From enrollment to late follow-up, up to 7 years | Urinary diversion specific impact on all cause mortality after surgery |
| Number of participants who will experience bladder cancer recurrence according to Urinary diversions | From enrollment to late follow-up, up to 7 years | Urinary diversion specific impact on bladder cancer recurrence |
| Number of participants who will experience bladder cancer recurrence after Robotic Surgery | From enrollment to late follow-up, up to 7 years | Robotic surgery specific impact on recurrence |
| Number of participants who will experience surgical complications after Robotic Surgery | From enrollment to late follow-up, up to 7 years | Robotic surgery specific impact on surgical complications |
Countries
Italy
Contacts
Primary ContactSimone Morselli, MD
Backup ContactSilvia Benemei, PhD
Outcome results
None listed