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| Name | Class |
|---|---|
| Bordeaux PharmacoEpi | OTHER |
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This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.
Over the last 15 years, robot-assisted laparoscopic radical prostatectomy surgery has seen a considerable rise in France. To date, it represents the most common surgical technique for radical prostatectomies, compared with standard procedure such as open retropubic radical prostatectomy or laparoscopic radical prostatectomy (8000 procedures/year, 40% of surgeries). In 2016, the French Health Authority (HAS) published a report on the robot-assisted laparoscopic radical prostatectomy practice that highlighted the small amount of available convincing data to provide evidence for a significant clinical benefit. There were no published data on overall or progression-free survival compared with other surgical procedures, with an important organizational and financial impact for healthcare institutions and patients. The question of the clinical benefit and the cost-effectiveness ratio of this surgical procedure is still relevant taking into account that randomized studies are difficult to carry out and that results of prospective registers will be available in many years. In this context, the use of the French National Claims Database (SNDS) appears to be the best short-term and reduced-cost solution to identify patients who benefited from the three surgical procedures since the rise of robotics. It would provide real-life data to national institutions in order to conclude on the opportunity to set a specific hospital tariff for the robot-assisted laparoscopic radical prostatectomy. This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with robot-assisted laparoscopic radical prostatectomy | |||
| Patients with open retropubic radical prostatectomy | |||
| Patients with laparoscopic radical prostatectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost / progression-free (without additional treatment) life-year saved 5 years after initial surgery | Progression-free survival requiring new treatment at 5 years will be calculated from :
A sensitivity analysis will be carried out after 1: 1 matching between subjects in each prostatectomy group. Estimation of the probability of event-free survival using the Kaplan-Meier estimator; Comparison of the risk of occurrence of each event between groups using a Cox proportional hazards model (after checking the underlying assumptions). The risk comparison will be measured using an hazard ratio, its 95% confidence interval and the p-value associated with the Wald test
| 5 years after initial surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost / life-year saved at 8 years. | Progression-free survival requiring new treatment at 5 years will be calculated from :
A sensitivity analysis will be carried out after 1: 1 matching between subjects in each prostatectomy group. Estimation of the probability of event-free survival using the Kaplan-Meier estimator; Comparison of the risk of occurrence of each event between groups using a Cox proportional hazards model (after checking the underlying assumptions). The risk comparison will be measured using an hazard ratio, its 95% confidence interval and the p-value associated with the Wald test
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost of robotic surgery. | None-adjusted estimation of cost-effectiveness ratios (95% confidence interval estimated by bootstrap) Net Monetary Benefit estimation of each surgical procedure (NMB = E x λ - C) with λ = differential cost-effectiveness threshold. | 5 years after initial surgery;8 years after initial surgery |
Inclusion Criteria:
Total retro-pubic prostatectomy (PTRP) identified in the SNDS by the standard, Classification of Medical Acts "JGFA006" act
Patient who has not received previous treatment for this cancer by hormone therapy, radiotherapy, brachytherapy or HiFU (treatments sought in the SNDS prior to surgery by the prescription of pharmaceutical specialties or the presence of CCAM procedures)
Exclusion Criteria:
Patient previously treated with another therapeutic modality for his prostate cancer (salvage prostatectomies after hormone therapy, radiotherapy, brachytherapy or HiFU)
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Three groups will be constituted according to surgical procedure: robot-assisted laparoscopic radical prostatectomy, open retropubic radical prostatectomy, and laparoscopic radical prostatectomy. All patients will be followed for at least 5 years and up to 8 years from the index date. Index date will be defined as the initial radical prostatectomy surgery performed between 2012-2015.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie PREAUBERT | Contact | 05 57 82 01 59 | nathalie.hayes@chu-bordeaux.fr | |
| Laurent PIAZZA | Contact | 05 57 82 08 22 | laurent.piazza@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Talence | 33400 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40493202 | Derived | Robert G, Blin P, Bladou F, Jove J, Ouattara E, Rouyer M, Droz-Perroteau C, Piazza L, Preaubert N. Comparative effectiveness of robot-assisted vs. open prostatectomy: a real-life nationwide study. World J Urol. 2025 Jun 10;43(1):367. doi: 10.1007/s00345-025-05715-0. |
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| 8 years after initial surgery |
| Urological hospitalizations within 90 days following the initial surgery. |
The initial hospital stay will be compared between the prostatectomy groups using standardized differences:
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| 90 days following the initial surgery |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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