Status:
RECRUITING
Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
Lead Sponsor:
Elsan
Conditions:
Prostate Cancer Surgery
Ambulatory Care
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to demonstrate that outpatient management for robotic-assisted radical prostatectomy is not inferior to inpatient management in terms of the occurrence of early post...
Eligibility Criteria
Inclusion
- Male, aged 18 and over
- Patient with prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy as a therapeutic option (with or without lymphadenectomy)
- Patient eligible for outpatient treatment :
- The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
- The patient has access to personal transport allowing, if necessary, return to the facility or another approved facility (transport time and distance from the facility are not exclusion factors)
- The patient has access to telephone communication facilities.
- The patient undertakes not to drive a vehicle and to be accompanied on his return home and for the next 24 hours by a responsible person who will be familiar with the monitoring instructions.
- The patient plans to remain in hospital overnight if this is deemed necessary by the department's doctors (operator and anaesthetist). The patient accepts this mode of care and its constraints.
- Participant affiliated to or benefiting from a social security scheme
- The participant has been informed and has given his/her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).
Exclusion
- Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy
- Patient participating in ongoing research or in a period of exclusion at the time of inclusion
- Refusal or inability to comply with the study protocol for any reason whatsoever
- Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT06822452
Start Date
December 30 2024
End Date
April 30 2030
Last Update
July 8 2025
Active Locations (12)
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1
Clinique Rhône Durance
Avignon, France, 84000
2
Clinique St Vincent
Besançon, France, 25000
3
Clinique St Augustin
Bordeaux, France, 33074
4
Polyclinique Médipôle St-Roch
Cabestany, France, 66330