Clinical trial NCT04638088: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: robot-assisted laparoscopy
laparotomy
conventional laparoscopy
prostatectomy
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient hospitalized for a planned radical prostactectomy .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score
timeFrame: 45 Days after the surgery
Secondary outcomes:
measure: impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy in radical prostatectomy on the erectile function assessed by the EPIC 50 score
timeFrame: 45 Days after the surgery
measure: impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE
timeFrame: up to 5 years after surgery
measure: impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score
timeFrame: upt to 5 years after the surgery
measure: Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
timeFrame: 12 months
measure: Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )
timeFrame: 3 years
measure: Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )
timeFrame: 5 years
measure: Prostate Specific Antigen (PSA) level
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Esquirol Saint Hilaire
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Beaumont
country: France
facility: Hôpital Privé La Châtaigneraie
city: Besançon
country: France
facility: Clinique St Vincent
city: Besançon
country: France
facility: Polyclinique de Franche Comté
city: Bordeaux
country: France
facility: Clinique de Saint Augustin
city: Brest
country: France
facility: Clinique Keraudren - CHPB
city: Brive-la-Gaillarde
country: France
facility: Centre Médico-Chirurgical Les Cèdres
city: Cabestany
country: France
facility: Polyclinique Médipôle Saint-Roch
city: Caen
country: France
facility: Polyclinique du Parc
city: Carcassonne
country: France
facility: Polyclinique Montréal
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Desertines
country: France
facility: Hôpital Privé Saint-François
city: La Seyne-sur-Mer
country: France
facility: Clinique Cap-d'Or
city: Le Mans
country: France
facility: Pôle Santé Sud
city: Limoges
country: France
facility: Clinique Emailleurs-Colombier
city: Limoges
country: France
facility: Polyclinique de Limoges
city: Metz
country: France
facility: Clinique Claude Bernard
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nantes
country: France
facility: Clinique Saint-Augustin
city: Nîmes
country: France
facility: Polyclinique Grand Sud
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Poitiers
country: France
facility: Polyclinique de Poitiers
city: Roanne
country: France
facility: Clinique du Renaison
city: Saint-Doulchard
country: France
facility: Clinique Guillaume De Varye
city: Soyaux
country: France
facility: Centre clinical
city: Stains
country: France
facility: Clinique de l'Estrée
city: Toulouse
country: France
facility: Clinique Ambroise Paré
city: Valenciennes
country: France
facility: Polyclinique Vauban
city: Vannes
country: France
facility: Hôpital privé Océane
Study officials:
affiliation: Elsan
name: Shahnaz KLOUCHE, MD
role: STUDY_DIRECTOR
affiliation: Elsan
name: Pierre-Thierry PIECHAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: