Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

Last updated: November 21, 2024
Sponsor: Elsan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

assessment of urinary function and erectil function before and after prostatectomy

Clinical Study ID

NCT04638088
GCS-ELSAN-0620
  • Ages > 18
  • Male

Study Summary

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient hospitalized for a planned radical prostatectomy

Exclusion

Exclusion Criteria:

  • Consent refusal from the patient

  • Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santépublique)

  • Absence of a French Health Care Insurance coverage

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: assessment of urinary function and erectil function before and after prostatectomy
Phase:
Study Start date:
March 08, 2021
Estimated Completion Date:
April 22, 2030

Study Description

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Connect with a study center

  • Clinique Esquirol Saint Hilaire

    Agen, 47000
    France

    Active - Recruiting

  • Clinique Rhône Durance

    Avignon, 84000
    France

    Completed

  • Hôpital Privé La Châtaigneraie

    Beaumont, 63110
    France

    Completed

  • Clinique St Vincent

    Besançon, 25000
    France

    Completed

  • Polyclinique de Franche Comté

    Besançon, 25000
    France

    Completed

  • Clinique de Saint Augustin

    Bordeaux, 33074
    France

    Completed

  • Clinique Keraudren - CHPB

    Brest, 29200
    France

    Active - Recruiting

  • Centre Médico-Chirurgical Les Cèdres

    Brive-la-Gaillarde, 19100
    France

    Active - Recruiting

  • Polyclinique Médipôle Saint-Roch

    Cabestany, 6633
    France

    Completed

  • Polyclinique du Parc

    Caen, 14000
    France

    Completed

  • Polyclinique Montréal

    Carcassonne, 11000
    France

    Active - Recruiting

  • Pôle Santé République

    Clermont-Ferrand, 63100
    France

    Active - Recruiting

  • Hôpital Privé Saint-François

    Desertines, 03630
    France

    Site Not Available

  • Clinique Cap-d'Or

    La Seyne-sur-Mer, 83500
    France

    Completed

  • Pôle Santé Sud

    Le Mans, 72000
    France

    Completed

  • Clinique Emailleurs-Colombier

    Limoges, 87000
    France

    Active - Recruiting

  • Polyclinique de Limoges

    Limoges, 87000
    France

    Completed

  • Clinique Claude Bernard

    Metz, 57070
    France

    Site Not Available

  • Polyclinique de Gentilly

    Nancy, 54100
    France

    Completed

  • Clinique Saint-Augustin

    Nantes, 44000
    France

    Completed

  • Polyclinique Grand Sud

    Nîmes, 30900
    France

    Completed

  • Polyclinique Les Fleurs

    Ollioules, 83190
    France

    Completed

  • Polyclinique de Poitiers

    Poitiers, 86000
    France

    Active - Recruiting

  • Clinique du Renaison

    Roanne, 42300
    France

    Active - Recruiting

  • Clinique Guillaume De Varye

    Saint-Doulchard, 18230
    France

    Completed

  • Centre clinical

    Soyaux, 16800
    France

    Completed

  • Clinique de l'Estrée

    Stains, 93240
    France

    Completed

  • Clinique Ambroise Paré

    Toulouse, 31082
    France

    Active - Recruiting

  • Polyclinique Vauban

    Valenciennes, 59300
    France

    Completed

  • Hôpital privé Océane

    Vannes, 56000
    France

    Completed

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