Clinical trial NCT06822452: Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed As an Outpatient Versus an Inpatient Procedure.
Official title: Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed As an Outpatient Versus an Inpatient Procedure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer Surgery
Ambulatory Care
Outpatient Surgery
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 510
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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-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: 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.

Primary outcomes:
measure: Early complication of robot-assisted prostatectomy
timeFrame: From the day of surgery to 8 days post-operative
Secondary outcomes:
measure: Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)
timeFrame: Day of surgery
measure: Rate of cancellation of outpatient treatment by the patient or his private environment
timeFrame: From enrollment to the day of surgery
measure: Rate of patients readmitted to hospital, either as emergencies or in the department
timeFrame: From hospital discharge to 8 days post-operative.
measure: Association of each early complication with treatment (outpatient or inpatient)
timeFrame: From hospitalisation discharge to 8 days post-operative
measure: Rate of patients having had at least one complication secondary to surgery
timeFrame: From 8 days to 45 days post-operative
measure: Rate of patients with at least one complication secondary to surgery
timeFrame: From 45 days to 6 months post-operative
measure: Patient's pre-operative stress/anxiety levels
timeFrame: 3 days before surgery, day of surgery and 2 days post-operative
measure: Patient satisfaction level
timeFrame: 2 days and 45 days post-operative
measure: Duration of surgery
timeFrame: Day of surgery
measure: Blood loss
timeFrame: Day of surgery
measure: Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery
timeFrame: Baseline and 45 days post-operative
measure: Evolution of urinary continence between 45 days and 6 months post-operatively and evolution of urinary function pre-operatively, at 45 days, at 6 months.
timeFrame: Baseline and 45 days, 6 months after surgery
measure: Recovery of erectile function
timeFrame: Baseline and 6 months post-operative
measure: Oncological recurrence and retreatment
timeFrame: From 45 days to 5 years after surgery
measure: Economic and social cost of patient care
timeFrame: From hospital discharge to 6 months post-operative
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Besançon
country: France
facility: Clinique St Vincent
city: Bordeaux
country: France
facility: Clinique St Augustin
city: Cabestany
country: France
facility: Polyclinique Médipôle St-Roch
city: Caen
country: France
facility: Polyclinique du Parc
city: Le Mans
country: France
facility: Pole Sante Sud-CMCM
city: Nancy
country: France
facility: Hôpital Privé Nancy Lorraine
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Saint-Herblain
country: France
facility: Polyclinique Santé Atlantique
city: Saint-Martin d'Hères
country: France
facility: Clinique Belledonne
city: Soyaux
country: France
facility: Centre clinical
city: Vannes
country: France
facility: Hôpital Privé Océane
Study officials:
References: