Real-life Study Based on the French National Healthcare Data System

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The University Hospital (Bordeaux, France) is conducting economic evaluation of robot-assistedlLaparoscopic radical prostatectomy vs conventionallLaparoscopic radical prostatectomy and open retropubic radical prostatectomy in prostate cancer: a real-life study based on the French National Healthcare Data System (SNDS) (ECOREPAR).

This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functionnal 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.  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, functionnal 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.

The University Hospital plans to recruit 84667 participants:

  • Patients with robot-assisted laparoscopic radical prostatectomy;
  • Patients with open retropubic radical prostatectomy;
  • Patients with laparoscopic radical prostatectomy.

The clinical trial started on January 1, 2020.

Three groups will be constituted. 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.

The real-life study is conducted in the following locations: Centre Hospitalier Universitaire de Bordeaux (33400 Talence, France). The platform Bordeaux PharmacoEpi stands as the сollaborator in this study.

For more details please follow the link: https://ichgcp.net/clinical-trials-registry/NCT04587284

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