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

NCT06822452 | Recruiting

• 2 other identifiers: PROSTAMBU2024-A01745-42
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 12

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

Conditions

Prostate Cancer Surgery; Ambulatory Care; Outpatient Surgery

Outcome Measures

Primary Outcomes (1)

• Early complication of robot-assisted prostatectomy

  The occurrence (yes/no) of at least one early complication of robot-assisted prostatectomy. The early clinical complications expected are : * Bleeding from trocar incision scars or surgical excision scars * Urinary leakage around the catheter * Retention due to bladder catheter clotting * Loss of bladder catheter * Signs of internal haemorrhage (within 24 hours) * Signs of biological deglobulation * Intestinal obstruction syndrome * Signs of urinary fistula * Infectious signs : fever \> 38°, chills * Thromboembolicaccidents * Nosocomial infections * Falls

  From the day of surgery to 8 days post-operative

Secondary Outcomes (15)

• Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)

  Day of surgery

• Rate of cancellation of outpatient treatment by the patient or his private environment

  From enrollment to the day of surgery

• Rate of patients readmitted to hospital, either as emergencies or in the department

  From hospital discharge to 8 days post-operative.

• Association of each early complication with treatment (outpatient or inpatient)

  From hospitalisation discharge to 8 days post-operative

• Rate of patients having had at least one complication secondary to surgery

  From 8 days to 45 days post-operative

Study Arms (2)

Outpatient procedure

EXPERIMENTAL

Procedure: radical prostatectomy

Inpatient procedure

ACTIVE COMPARATOR

Procedure: radical prostatectomy

Interventions

radical prostatectomy PROCEDURE

Robot-assisted

Inpatient procedure; Outpatient procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy
• 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.

Sponsors & Collaborators

• Elsan: lead

Study Sites (12)

Clinique Rhône Durance

Avignon, 84000, France

NOT YET RECRUITING

Clinique St Vincent

Besançon, 25000, France

RECRUITING

Clinique St Augustin

Bordeaux, 33074, France

RECRUITING

Polyclinique Médipôle St-Roch

Cabestany, 66330, France

RECRUITING

Polyclinique du Parc

Caen, 14000, France

NOT YET RECRUITING

Pole Sante Sud-CMCM

Le Mans, 72100, France

RECRUITING

Hôpital Privé Nancy Lorraine

Nancy, 54100, France

NOT YET RECRUITING

Polyclinique Les Fleurs

Ollioules, 83190, France

RECRUITING

Polyclinique Santé Atlantique

Saint-Herblain, 44800, France

NOT YET RECRUITING

Clinique Belledonne

Saint-Martin-d'Hères, 38400, France

RECRUITING

Centre clinical

Soyaux, 16800, France

NOT YET RECRUITING

Hôpital Privé Océane

Vannes, 56000, France

RECRUITING

Central Study Contacts

Charlène PY, Eng

CONTACT

+33556003048; charlene.py@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): April 30, 2030
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)