Prostate Cancer Clinical Trial
— ECOREPAROfficial title:
Economic Evaluation of Robot-assisted Laparoscopic Radical Prostatectomy vs Conventional Laparoscopic Radical Prostatectomy and Open Retropubic Radical Prostatectomy in Prostate Cancer: a Real-life Study Based on the French National Healthcare Data System (SNDS)
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.
Status | Recruiting |
Enrollment | 84667 |
Est. completion date | January 1, 2023 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Total retro-pubic prostatectomy (PTRP) identified in the SNDS by the standard, Classification of Medical Acts "JGFA006" act - Laparoscopic total prostatectomy (PTL) identified in the SNDS by the CCAM "JGFC001" act and the health and social establishment files number of centers not equipped with a surgical robot - Robot-assisted total prostatectomy (PTRA) identified in the SNDS by the CCAM "JGFC001" act and the health and social establishment files number of centers equipped with a surgical robot for more than 12 months and having a rate of use of this technique for more than 95% minimally invasive prostatectomies. The number of PTRA will be identified by a survey in each center and the manufacturer's data as explained above 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 operated for laparoscopic radical prostatectomy or robot-assisted laparoscopic radical prostatectomy in a center equipped with a surgical robot but with a rate of use of this technique less than 95% (centers offering different minimally invasive approaches that do not allow to define if the intervention was performed in robotic surgery or in open surgery) - Patient operated for a robot-assisted laparoscopic radical prostatectomy in a center having started a robotic activity for less than 12 months Patient previously treated with another therapeutic modality for his prostate cancer (salvage prostatectomies after hormone therapy, radiotherapy, brachytherapy or HiFU) |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Talence |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Bordeaux PharmacoEpi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 ? - C) with ? = differential cost-effectiveness threshold. | 5 years after initial surgery;8 years after initial surgery | |
Other | Urological hospitalizations within 90 days following the initial surgery. | The initial hospital stay will be compared between the prostatectomy groups using standardized differences: without adjustment, from the overall population; after adjustment for the propensity score, from the overall population; from the matched groups 1: 1. |
90 days following the initial surgery | |
Primary | 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 : Death within 5 years of surgery Occurrence, over the period (5 years), of recurrences / progressions requiring additional treatment by radiotherapy and / or hormone therapy. 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 without adjustment, from the overall population; after adjustment for the propensity score, from the overall population; from matched groups 1: 1. |
5 years after initial surgery | |
Secondary | Incremental cost / life-year saved at 8 years. | Progression-free survival requiring new treatment at 5 years will be calculated from : Death within 8 years of surgery Occurrence, over the period (8 years), of recurrences / progressions requiring additional treatment by radiotherapy and / or hormone therapy. 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 without adjustment, from the overall population; after adjustment for the propensity score, from the overall population; from matched groups 1: 1. |
8 years after initial surgery |
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