Robotic Radical Cystectomy Outcomes

Recruiting

• Conditions: Bladder Cancer; Oncology; Recurrence; Muscle-Invasive Bladder Carcinoma; Surgery

• Registration Number: NCT04900558
• Lead Sponsor: University of Florence

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-29
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25
• Primary Completion: 2031-02-01
• Study Completion: 2038-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 bladder cancer	From enrollment to late follow-up, up to 7 years	Bladder Cancer Specific Mortality after surgery
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 Outcome Measures

Name	Time	Method
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 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
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 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 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 experience surgical complications after Robotic Surgery	From enrollment to late follow-up, up to 7 years	Robotic surgery specific impact on surgical complications
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 experience bladder cancer recurrence after Robotic Surgery	From enrollment to late follow-up, up to 7 years	Robotic surgery specific impact on recurrence

Trial Locations

Locations (1)

Careggi University Hospital; 🇮🇹 Florence, Tuscany, Italy