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Recruiting NCT04638088

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

Conditions: Prostate Cancer

Sponsor: Elsan

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
assessment of urinary function and erectil function before and after prostatectomy
OTHER
Locations 30
France (30)
Clinique Esquirol Saint Hilaire
Agen
Clinique Rhône Durance
Avignon
COMPLETED
Hôpital Privé La Châtaigneraie
Beaumont
COMPLETED
Clinique St Vincent
Besançon
COMPLETED
Polyclinique de Franche Comté
Besançon
COMPLETED
Clinique de Saint Augustin
Bordeaux
COMPLETED
Clinique Keraudren - CHPB
Brest
Centre Médico-Chirurgical Les Cèdres
Brive-la-Gaillarde
Pascal BOURNEL, MD
Polyclinique Médipôle Saint-Roch
Cabestany
COMPLETED
Polyclinique du Parc
Caen
COMPLETED
Polyclinique Montréal
Carcassonne
Frédéric VAVDIN, MD
Pôle Santé République
Clermont-Ferrand
Hôpital Privé Saint-François
Désertines
WITHDRAWN
Clinique Cap-d'Or
La Seyne-sur-Mer
COMPLETED
Pôle Santé Sud
Le Mans
COMPLETED
Clinique Emailleurs-Colombier
Limoges
Nicolas LESAUX, MD
Polyclinique de Limoges
Limoges
COMPLETED
Clinique Claude Bernard
Metz
WITHDRAWN
Polyclinique de Gentilly
Nancy
COMPLETED
Clinique Saint-Augustin
Nantes
COMPLETED
Polyclinique Grand Sud
Nîmes
COMPLETED
Polyclinique Les Fleurs
Ollioules
COMPLETED
Polyclinique de Poitiers
Poitiers
Christian PEYRET, MD
Clinique du Renaison
Roanne
Thierry BETHMONT, MD
Clinique Guillaume De Varye
Saint-Doulchard
COMPLETED
Centre clinical
Soyaux
COMPLETED
Clinique de l'Estrée
Stains
COMPLETED
Clinique Ambroise Paré
Toulouse
Frédéric JONCA, MD
Polyclinique Vauban
Valenciennes
COMPLETED
Hôpital privé Océane
Vannes
COMPLETED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
08.03.2021
Completion date
30.04.2030
Registry ID
NCT04638088
Source
clinicaltrials.gov
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