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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,000
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
Clinique Esquirol Saint Hilaire
Agen, France
RECRUITINGClinique Rhône Durance
Avignon, France
COMPLETEDHôpital Privé La Châtaigneraie
Beaumont, France
COMPLETEDClinique St Vincent
Besançon, France
COMPLETEDImpact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score
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)
Time frame: 45 Days after the surgery
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
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)
Time frame: 45 Days after the surgery
impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE
Time frame: up to 5 years after surgery
impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score
Time frame: upt to 5 years after the surgery
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Time frame: 12 months
Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )
Time frame: 3 years
Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )
Time frame: 5 years
Prostate Specific Antigen (PSA) level
measures of the level of PSA in a man's blood
Time frame: up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Polyclinique de Franche Comté
Besançon, France
COMPLETEDClinique de Saint Augustin
Bordeaux, France
COMPLETEDClinique Keraudren - CHPB
Brest, France
RECRUITINGCentre Médico-Chirurgical Les Cèdres
Brive-la-Gaillarde, France
RECRUITINGPolyclinique Médipôle Saint-Roch
Cabestany, France
COMPLETEDPolyclinique du Parc
Caen, France
COMPLETED...and 20 more locations