Prostatic Neoplasms
Conditions
Keywords
Radical prostatectomie, Robotic assistance, Laparotomy
Brief summary
The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy. The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).
Detailed description
The secondary objectives of this research are to compare the following between the two groups: * The actual cost of the surgical prostatectomy. * Erectile function at 0, 1, 6, 12 and 24 * Oncological results at 1, 6, 12 and 24 months. * Functional results at 0, 1, 6, 12 and 24 months. * Quality of life at 0, 1, 6, 12 and 24 months. * Complication rates at 1 and 24 months.
Interventions
PROCEDURERobot-assisted radical prostatectomy
Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S
PROCEDURERadical prostatectomy via laparotomy
Classic radical prostatectomy via open retropubic approach
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The patient must have given his informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 24 months of follow up * Patient has localised prostate cancer * Patient is eligible for radical prostatectomy
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Patient has a contraindication for a treatment necessary for this study * Patients with psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall cost (€) of patient care | 60 months | Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 5 years. All medical resources consumed will be evaluated during the first 5 years after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in erectile function | baseline to 1 month | the International Index of Erectile Function (IIEF-15) will be used. |
| the % of positive margins after resection | baseline (Day 1) | — |
| presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) | 1 month | — |
| Cost (€) of surgery via micro-costing | Day 1 | All human and material resources necessary for carrying out a prostatectomy will be evaluated. |
| Change in quality of life as estimated by the QLQC-30 questionnaire | baseline to 1 month | — |
| Presence/absence of complications (Clavien) | 1 month | The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.) |
| Presence/absence of complications (Pentafecta) | 1 month | The Pentafecta classification will be used. |
| Change in function as estimated by the PR25 questionnaire | baseline to 1 month | — |
Countries
France
Outcome results
None listed