Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
Recruiting · NCT04638088 · Observational (researchers observe without assigning treatment) · Lead sponsor: Elsan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- patient hospitalized for a planned radical prostatectomy
Exclusion criteria
- Consent refusal from the patient
- Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
- Absence of a French Health Care Insurance coverage
Where it is running
30 locations listed.
- Clinique Esquirol Saint Hilaire - Agen, France
- Clinique Rhône Durance - Avignon, France
- Hôpital Privé La Châtaigneraie - Beaumont, France
- Clinique St Vincent - Besançon, France
- Polyclinique de Franche Comté - Besançon, France
- Clinique de Saint Augustin - Bordeaux, France
- Clinique Keraudren - CHPB - Brest, France
- Centre Médico-Chirurgical Les Cèdres - Brive-la-Gaillarde, France
- Polyclinique Médipôle Saint-Roch - Cabestany, France
- Polyclinique du Parc - Caen, France
- Polyclinique Montréal - Carcassonne, France
- Pôle Santé République - Clermont-Ferrand, France
- Hôpital Privé Saint-François - Désertines, France
- Clinique Cap-d'Or - La Seyne-sur-Mer, France
- Pôle Santé Sud - Le Mans, France
- Clinique Emailleurs-Colombier - Limoges, France
- Polyclinique de Limoges - Limoges, France
- Clinique Claude Bernard - Metz, France
- Polyclinique de Gentilly - Nancy, France
- Clinique Saint-Augustin - Nantes, France
- Polyclinique Grand Sud - Nîmes, France
- Polyclinique Les Fleurs - Ollioules, France
- Polyclinique de Poitiers - Poitiers, France
- Clinique du Renaison - Roanne, France
- Clinique Guillaume De Varye - Saint-Doulchard, France
- Centre clinical - Soyaux, France
- Clinique de l'Estrée - Stains, France
- Clinique Ambroise Paré - Toulouse, France
- Polyclinique Vauban - Valenciennes, France
- Hôpital privé Océane - Vannes, France