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

Elsan

Status

Enrolling

Conditions

Outpatient Surgery

Prostate Cancer Surgery

Ambulatory Care

Treatments

Procedure: radical prostatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06822452

PROSTAMBU

2024-A01745-42 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

510 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.