Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Overall cost (€) of patient care
- Status
- Completed
- Last Updated
- 4 months ago
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.
Investigators
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
Outcomes
Primary Outcomes
Overall cost (€) of patient care
Time Frame: 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 Outcomes
- Presence/absence of complications (Pentafecta)(24 months)
- Change in function as estimated by the PR25 questionnaire(baseline to 24 months)
- Cost (€) of surgery via micro-costing(Day 1)
- Change in erectile function(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)(24 months)
- Change in quality of life as estimated by the QLQC-30 questionnaire(baseline to 24 months)
- Presence/absence of complications (Clavien)(24 months)