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

Last updated: February 6, 2025
Sponsor: Elsan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

radical prostatectomy

Clinical Study ID

NCT06822452
PROSTAMBU
2024-A01745-42
  • Ages > 18
  • Male

Study 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

Inclusion Criteria:

  • Male, aged 18 and over

  • Patient with prostate cancer for which the multidisciplinary meeting has proposedradical 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 duringsurgical consultations and the anaesthetic consultation.

  2. The patient has access to personal transport allowing, if necessary, return tothe facility or another approved facility (transport time and distance from thefacility 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 hisreturn home and for the next 24 hours by a responsible person who will befamiliar with the monitoring instructions.

  5. The patient plans to remain in hospital overnight if this is deemed necessaryby the department's doctors (operator and anaesthetist). The patient acceptsthis 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 writtenconsent (at the latest on the day of inclusion and before any examination requiredby the research).

Exclusion

Exclusion Criteria:

  • Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy orfocal therapy

  • Patient participating in ongoing research or in a period of exclusion at the time ofinclusion

  • Refusal or inability to comply with the study protocol for any reason whatsoever

  • Protected participant: adult under guardianship, curatorship or other legalprotection, deprived of liberty by judicial or administrative decision.

Study Design

Total Participants: 510
Treatment Group(s): 1
Primary Treatment: radical prostatectomy
Phase:
Study Start date:
December 30, 2024
Estimated Completion Date:
April 30, 2030

Connect with a study center

  • Clinique Rhône Durance

    Avignon, 84000
    France

    Site Not Available

  • Clinique St Vincent

    Besançon, 25000
    France

    Site Not Available

  • Clinique St Augustin

    Bordeaux, 33074
    France

    Site Not Available

  • Polyclinique Médipôle St-Roch

    Cabestany, 66330
    France

    Site Not Available

  • Polyclinique du Parc

    Caen, 14000
    France

    Site Not Available

  • Pole Sante Sud-CMCM

    Le Mans, 72100
    France

    Site Not Available

  • Hôpital Privé Nancy Lorraine

    Nancy, 54100
    France

    Site Not Available

  • Polyclinique Les Fleurs

    Ollioules, 83190
    France

    Site Not Available

  • Polyclinique Santé Atlantique

    Saint-Herblain, 44800
    France

    Site Not Available

  • Clinique Belledonne

    Saint-Martin d'Hères, 38400
    France

    Active - Recruiting

  • Centre clinical

    Soyaux, 16800
    France

    Site Not Available

  • Hôpital Privé Océane

    Vannes, 56000
    France

    Active - Recruiting

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