RecruitingNot ApplicableNCT06822452

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


Sponsor

Elsan

Enrollment

510 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares the early complication rates of robotic-assisted radical prostatectomy (prostate removal surgery) performed as a same-day outpatient procedure versus a standard inpatient stay requiring overnight hospitalization. **You may be eligible if...** - You are a male aged 18 or older - You have prostate cancer for which surgery (radical prostatectomy) has been recommended - You are able to follow post-surgical instructions at home - You have access to personal transport and telephone communication - You are eligible for outpatient treatment per pre-surgical consultations **You may NOT be eligible if...** - You have serious medical conditions that require extended hospitalization - You live alone without support at home after surgery - You have conditions that your surgeon or anesthetist determines make outpatient surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREradical prostatectomy

Robot-assisted


Locations(12)

Clinique Rhône Durance

Avignon, France

Clinique St Vincent

Besançon, France

Clinique St Augustin

Bordeaux, France

Polyclinique Médipôle St-Roch

Cabestany, France

Polyclinique du Parc

Caen, France

Pole Sante Sud-CMCM

Le Mans, France

Hôpital Privé Nancy Lorraine

Nancy, France

Polyclinique Les Fleurs

Ollioules, France

Polyclinique Santé Atlantique

Saint-Herblain, France

Clinique Belledonne

Saint-Martin-d'Hères, France

Centre clinical

Soyaux, France

Hôpital Privé Océane

Vannes, France

View Full Details on ClinicalTrials.gov

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NCT06822452


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