Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
- Conditions
- Prostate Cancer
- Interventions
- Other: assessment of urinary function and erectil function before and after prostatectomy
- Registration Number
- NCT04638088
- Lead Sponsor
- Elsan
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 2000
- patient hospitalized for a planned radical prostatectomy
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description conventional laparoscopy assessment of urinary function and erectil function before and after prostatectomy radical prostatectomy performed by conventional laparoscopy robot-assisted laparoscopy assessment of urinary function and erectil function before and after prostatectomy radical prostatectomy performed by robot-assisted laparoscopy laparotomy assessment of urinary function and erectil function before and after prostatectomy radical prostatectomy performed by laparotomy
- Primary Outcome Measures
Name Time Method Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score 45 Days after the surgery Comparison of the prostatectomy performed by robot assisted laparoscopy or conventional laparoscopy and by surgical laparotomy on the urinary function assessed by the EPIC 50 score (Expanded Prostate Cancer Index Composite)
- Secondary Outcome Measures
Name Time Method Prostate Specific Antigen (PSA) level up to 5 years measures of the level of PSA in a man's blood
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 45 Days after the surgery impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy on the erectile function assessed by he EPIC 50 score (Expanded Prostate Cancer Index Composite)
impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score upt to 5 years after the surgery Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score 12 months Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction ) 3 years Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction ) 5 years impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE up to 5 years after surgery
Trial Locations
- Locations (30)
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