Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy

Study Overview
=================
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.

Official Title
-----------------
Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

Conditions
-----------------
Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic assistance, Nîmes<br>The patients in this group will undergo robot-assisted radial prostatectomy at the University Hospital of Nîmes. | |
| Laparotomy, Marseilles<br>The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cost (€) of patient care | 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. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost (€) of surgery via micro-costing | All human and material resources necessary for carrying out a prostatectomy will be evaluated. | Day 1 | 
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 1 month | 
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 6 months | 
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 12 months | 
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 24 months | 
| the % of positive margins after resection |  | baseline (Day 1) | 
| presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) |  | 1 month | 
| presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) |  | 6 months | 
| presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) |  | 12 months | 
| presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) |  | 24 months | 
| Change in function as estimated by the PR25 questionnaire |  | baseline to 1 month | 
| Change in function as estimated by the PR25 questionnaire |  | baseline to 6 months | 
| Change in function as estimated by the PR25 questionnaire |  | baseline to 12 months | 
| Change in function as estimated by the PR25 questionnaire |  | baseline to 24 months | 
| Change in quality of life as estimated by the QLQC-30 questionnaire |  | baseline to 1 month | 
| Change in quality of life as estimated by the QLQC-30 questionnaire |  | baseline to 6 months | 
| Change in quality of life as estimated by the QLQC-30 questionnaire |  | baseline to 12 months | 
| Change in quality of life as estimated by the QLQC-30 questionnaire |  | baseline to 24 months | 
| Presence/absence of complications (Clavien) | 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.) | 1 month | 
| Presence/absence of complications (Clavien) | 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.) | 24 months | 
| Presence/absence of complications (Pentafecta) | The Pentafecta classification will be used. | 1 month | 
| Presence/absence of complications (Pentafecta) | The Pentafecta classification will be used. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radical prostatectomie, Robotic assistance, Laparotomy