Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorElsan

About this trial

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-operative complications.

Researchers will compare outpatient robot-assisted radical prostatectomy to inpatient procedure.

Participants will:

* Visit the clinic after the operation once at 45 days, 6 months and once a year for up to 5 years for check-ups and tests. * Answer survey questions about urinary and erectil functions, stress and anxiety, satisfaction, quality of life for 6 months * Keep a diary to record procedures and treatments related to the care provided

Eligibility criteria

Qualifiers

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)

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • radical prostatectomy

Treatment groups

510 Participants
are divided into 2 treatment groups

Sponsors and collaborators