Robotic Radical Cystectomy Outcomes

Study Overview
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Brief Summary
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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

Official Title
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Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy

Conditions
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Muscle-Invasive Bladder Carcinoma, Recurrence, Surgery, Oncology, Bladder Cancer

Intervention / Treatment
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* Procedure: Radical Cystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radical Cystectomy<br>Patients who underwent radical cystectomy for bladder cancer in our centre | Procedure: Radical Cystectomy<br>* 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...<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who will die from bladder cancer | Bladder Cancer Specific Mortality after surgery | From enrollment to late follow-up, up to 7 years | 
| Number of participants who will experience bladder cancer recurrence | Bladder Cancer Recurrence | From enrollment to late follow-up, up to 7 years | 
| Number of participants who will die from all causes | All cause mortality after surgery | From enrollment to late follow-up, up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who will die from bladder cancer after Robotic Surgery | Robotic surgery specific impact on survival | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | From enrollment to late follow-up, up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical Cystectomy, Cystectomy, Ileal Conduit, Neobladder, Bladder Cancer, Muscle Invasive Bladder Cancer