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Recruiting NCT04900558

Robotic Radical Cystectomy Outcomes

— Observational Bladder Cancer Muscle-Invasive Bladder Carcinoma Oncology Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radical Cystectomy.
Who it may be relevant to
Registry conditions: Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Oncology, Recurrence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure Radical 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...

Primary outcome measures

  • Number of participants who will die from bladder cancer [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will experience bladder cancer recurrence [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will die from all causes [Time frame: From enrollment to late follow-up, up to 7 years]
Secondary outcome measures (9)
  • Number of participants who will die from bladder cancer after Robotic Surgery [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will experience bladder cancer recurrence after Robotic Surgery [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will experience surgical complications after Robotic Surgery [Time frame: From enrollment to late follow-up, up to 7 years]
  • Variation in Quality of Life questionnaire after Robotic Surgery [Time frame: From enrollment to late follow-up, up to 7 years]
  • Variation in Quality of Life questionnaire according to Urinary diversions [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will experience surgical complications according to Urinary diversions [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will experience bladder cancer recurrence according to Urinary diversions [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will die from bladder cancer according to Urinary diversions [Time frame: From enrollment to late follow-up, up to 7 years]
  • Number of participants who will die from all causes according to Urinary diversions [Time frame: From enrollment to late follow-up, up to 7 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Careggi University Hospital — Florence

Identifiers

NCT: NCT04900558 · 19303_oss

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗