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Clinical Trials/NCT04900558
NCT04900558
Recruiting
N/A

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

University of Florence1 site in 1 country500 target enrollmentApril 29, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
University of Florence
Enrollment
500
Locations
1
Primary Endpoint
Number of participants who will experience bladder cancer recurrence
Status
Recruiting
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 29, 2021
End Date
February 1, 2038
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Simone Morselli

PhD Student

University of Florence

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

Outcomes

Primary Outcomes

Number of participants who will experience bladder cancer recurrence

Time Frame: From enrollment to late follow-up, up to 7 years

Bladder Cancer Recurrence

Number of participants who will die from bladder cancer

Time Frame: 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

Time Frame: From enrollment to late follow-up, up to 7 years

All cause mortality after surgery

Secondary Outcomes

  • Number of participants who will experience surgical complications according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will experience bladder cancer recurrence according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will die from all causes according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Variation in Quality of Life questionnaire after Robotic Surgery(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will experience bladder cancer recurrence after Robotic Surgery(From enrollment to late follow-up, up to 7 years)
  • Variation in Quality of Life questionnaire according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will die from bladder cancer according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will die from bladder cancer after Robotic Surgery(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will experience surgical complications after Robotic Surgery(From enrollment to late follow-up, up to 7 years)

Study Sites (1)

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