About this trial
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
This trial does not accept healthy volunteersQualifiers
patient hospitalized for a planned radical prostatectomy
Disqualifiers
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
Trial population
patient hospitalized for a planned radical prostactectomy .
Trial design
Cohort
Prospective
Treatments tested in this trial
assessment of urinary function and erectil function before and after prostatectomy
Other interventionassessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
Treatment groups
Trial outcomes
Primary outcomes
Impact 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)
Secondary outcomes
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)
impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE
impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score
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