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Brief Title: Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
Official Title: Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.
Study ID: NCT04638088
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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, Desertines, , 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
Name: Shahnaz KLOUCHE, MD
Affiliation: Elsan
Role: STUDY_DIRECTOR
Name: Pierre-Thierry PIECHAUD, MD
Affiliation: Elsan
Role: PRINCIPAL_INVESTIGATOR