Status: Planned First registered on: 29/01/2020
Last updated on: 31/01/2020
1. Study identification
EU PAS Register NumberEUPAS33290
Official titleEconomic 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).
Study title acronymECOREPAR
Study typeObservational study
Brief description of the studyOver 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameUniversity hospital of Bordeaux
Centre locationBordeaux, France
Details of (Primary) lead investigator
Title Ms
Last name HAYES
First name Nathalie
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

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
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/09/2019
Start date of data collection01/01/2020
Start date of data analysis01/09/2020
Date of interim report, if expected01/04/2021
Date of final study report01/01/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyMinistère des Solidarités et de la Santé - Direction Générale de l'Offre de Soins – PRME 2018100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name HAYES
First name Nathalie
Address line 1Bordeaux University Hospital – Clinical Research and Innovation Direction
Address line 2Department of Innovation and Economic Evaluation 
Address line 3Direction Générale, 12 rue Dubernat 
CityTalence cedex 
Postcode33404 
CountryFrance
Phone number (incl. country code)33557820159 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Ms 
Last name DOUBLET 
First name Aline 
Address line 1Bordeaux University Hospital 
Address line 2Clinical Research and Innovation Direction 
Address line 3Direction Générale, 12 rue Dubernat 
CityTalence cedex 
Postcode33404 
CountryFrance 
Phone number (incl. country code)33557820853 
Alternative phone number 
Fax number (incl. country code) 
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