Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06822452

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

Led by Elsan · Updated on 2025-07-08

510

Participants Needed

12

Research Sites

278 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, aged 18 and over
  • Diagnosed with prostate cancer recommended for radical prostatectomy (with or without lymphadenectomy)
  • Eligible for outpatient treatment by agreeing to follow all medical instructions during consultations
  • Has access to personal transport for return to the facility if needed
  • Has access to telephone communication
  • Agrees not to drive and to be accompanied home and for 24 hours post-procedure by a responsible person
  • Will stay overnight in hospital if deemed necessary by doctors and accepts this care mode
  • Affiliated with or benefits from a social security scheme
  • Has given free, informed, and written consent before any study-related examinations
Not Eligible

You will not qualify if you...

  • Previously treated for prostate cancer with brachytherapy, radiotherapy, or focal therapy
  • Currently participating in other research or within an exclusion period
  • Refuses or is unable to follow the study protocol for any reason
  • Under legal protection such as guardianship, curatorship, or deprived of liberty by judicial or administrative decision

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Clinique Rhône Durance

Avignon, France, 84000

Not Yet Recruiting

2

Clinique St Vincent

Besançon, France, 25000

Actively Recruiting

3

Clinique St Augustin

Bordeaux, France, 33074

Actively Recruiting

4

Polyclinique Médipôle St-Roch

Cabestany, France, 66330

Actively Recruiting

5

Polyclinique du Parc

Caen, France, 14000

Not Yet Recruiting

6

Pole Sante Sud-CMCM

Le Mans, France, 72100

Actively Recruiting

7

Hôpital Privé Nancy Lorraine

Nancy, France, 54100

Not Yet Recruiting

8

Polyclinique Les Fleurs

Ollioules, France, 83190

Actively Recruiting

9

Polyclinique Santé Atlantique

Saint-Herblain, France, 44800

Not Yet Recruiting

10

Clinique Belledonne

Saint-Martin-d'Hères, France, 38400

Actively Recruiting

11

Centre clinical

Soyaux, France, 16800

Not Yet Recruiting

12

Hôpital Privé Océane

Vannes, France, 56000

Actively Recruiting

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Research Team

C

Charlène PY, Eng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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