Robotic Radical Cystectomy Outcomes

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900558
• Other study ID #: 19303_oss
• Status: Recruiting
• Start date: April 29, 2021
• Est. completion date: February 1, 2038

Study information

• Verified date: May 2021
• Source: University of Florence
• Contact: Simone Morselli, MD
• Phone: 3473050852
• Email: simone.morselli.89[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2038
• Est. primary completion date: February 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Muscle-Invasive Bladder Carcinoma
• Oncology
• Recurrence
• Surgery
• Urinary Bladder Neoplasms

Intervention

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...

Locations

Country	Name	City	State
Italy	Careggi University Hospital	Florence	Tuscany

Sponsors (2)

Lead Sponsor	Collaborator
University of Florence	Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants who will experience bladder cancer recurrence	Bladder Cancer Recurrence	From enrollment to late follow-up, up to 7 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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