Prostate Cancer
Conditions
Keywords
robot-assisted laparoscopy, laparotomy, conventional laparoscopy, prostatectomy
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.
Interventions
OTHERassessment of urinary function and erectil function before and after prostatectomy
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
Sponsors
Elsan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 urinary function assessed by EPIC 50 SCORE | 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 | 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 | — |
| Prostate Specific Antigen (PSA) level | up to 5 years | measures of the level of PSA in a man's blood |
Countries
France
Contacts
CONTACTShahnaz KLOUCHE, MD
STUDY_DIRECTORShahnaz KLOUCHE, MD
Elsan
PRINCIPAL_INVESTIGATORPierre-Thierry PIECHAUD, MD
Elsan
Outcome results
None listed