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

Launched by ELSAN · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether having robotic-assisted prostate surgery as an outpatient (where you go home the same day) is just as safe as having it as an inpatient (where you stay in the hospital overnight). The main goal is to see if patients who have the outpatient procedure experience fewer early complications after their surgery compared to those who stay in the hospital.

Eligible participants are men aged 18 and older who have been diagnosed with prostate cancer and have been advised to undergo surgery. If you join the study, you will need to visit the clinic for check-ups at 45 days, 6 months, and once a year for up to 5 years. You’ll also be asked to complete surveys about your urinary and sexual functions, anxiety levels, and overall quality of life for the first 6 months after surgery. Additionally, you'll keep a diary of your treatments and any care you receive. Remember, it’s important to have someone to help you get home after the procedure and to follow the doctor's instructions closely.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 :
• • 1. The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
• • 2. 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)
• • 3. The patient has access to telephone communication facilities.
• • 4. 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.
• • 5. 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 Criteria:
• • 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.