Study identification

PURI

https://redirect.ema.europa.eu/resource/43648

EU PAS number

EUPAS33290

Study ID

43648

Official title and acronym

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). (ECOREPAR)

DARWIN EU® study

No

Study countries

France

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, 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.

Study status

Finalised
Research institution and networks

Institutions

University Hospital of Bordeaux, Clinical Research and innovation direction - Department of innovation and economic evaluation France, University Hospital of Bordeaux, Department of Urology and Kidney Transplantation France

Contact details

Laurent PIAZZA

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Ministère des Solidarités et de la Santé - Direction Générale de l'Offre de Soins – PRME 2018
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable