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)

Last updated: October 16, 2020
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT04587284
CHUBX 2018/72
  • Ages > 18
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

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 witha 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 asurgical robot for more than 12 months and having a rate of use of this technique formore than 95% minimally invasive prostatectomies. The number of PTRA will beidentified 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 theprescription of pharmaceutical specialties or the presence of CCAM procedures)

Exclusion

Exclusion Criteria:

  • Patient operated for laparoscopic radical prostatectomy or robot-assisted laparoscopicradical prostatectomy in a center equipped with a surgical robot but with a rate ofuse of this technique less than 95% (centers offering different minimally invasiveapproaches that do not allow to define if the intervention was performed in roboticsurgery or in open surgery)

  • Patient operated for a robot-assisted laparoscopic radical prostatectomy in a centerhaving 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)

Study Design

Total Participants: 84667
Study Start date:
January 01, 2020
Estimated Completion Date:
January 01, 2023

Study Description

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.

Connect with a study center

  • Centre Hospitalier Universitaire de Bordeaux

    Talence, 33400
    France

    Active - Recruiting

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