Robotic Radical Cystectomy Outcomes

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

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

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Surgery; Bladder Cancer; Muscle-Invasive Bladder Carcinoma; Oncology
• Intervention / Treatment: Procedure: Radical Cystectomy

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Simone Morselli, MD; Phone Number: 3473050852; Email: simone.morselli.89@gmail.com
• Study Contact Backup: Name: Silvia Benemei, PhD; Email: silvia.benemei@unifi.it

Study Locations

• Italy
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Recruiting
      • Careggi University Hospital
      • Sub-Investigator: Mauro Gacci, MD
      • Sub-Investigator: Riccardo Campi, MD
      • Contact: Arcangelo Sebastianelli, MD; Email: arcangelo.sebastianelli@gmail.com
      • Principal Investigator: Simone Morselli, MD
      • Sub-Investigator: Maria Rosaria Raspollini, MD
      • Principal Investigator: Arcangelo Sebastianelli, MD
      • Sub-Investigator: Donata Villari, MD
      • Sub-Investigator: Graziano Vignolini, MD
      • Sub-Investigator: Saverio Giancane, MD
      • Sub-Investigator: Pietro Spatafora, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is made up of patients who underwent radical cystectomy at AOU Careggi, SOD Robotic Urological Surgery, Minimally Invasive and Renal Transplantation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radical Cystectomy; Patients who underwent radical cystectomy for bladder cancer in our centre	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...

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florence
• Collaborators: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Arcangelo Sebastianelli, MD, Careggi Hospital, University of Florence; Principal Investigator: Simone Morselli, MD, University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Anticipated): February 1, 2031
• Study Completion (Anticipated): February 1, 2038

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Radical Cystectomy; Cystectomy; Bladder Cancer; Muscle Invasive Bladder Cancer; Neobladder; Ileal Conduit
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Disease Attributes; Recurrence; Urinary Bladder Neoplasms
• Other Study ID Numbers: 19303_oss

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No