R-RCT from the Obesity registry resolve uncertainty about comparative effectiveness
28 Apr 2024

In the recently published BEST trial(1,2), a Registry-based Randomized Clinical Trial (R-RCT), they answered the uncertainty of comparative efficacy and safety for two surgical interventions.

Based on this study, including 1735, it was possible to demonstrate that both procedures have a low perioperative risk without clinically significant differences between groups(2).

The registry has been used for scientific research since the start of 2007, resulting in more than 150 scientific publications. There has been a continuous effort to ensure the high quality of the data. This was also demonstrated in two studies (3,4) assessing the coverage of the registry compared to the national patient registry and the data quality. The registry includes 294 variables (5) with 99.0 % exact agreement based on a review of 100 200 unique entries(3).

“Results from the Scandinavian Obesity Surgery Registry: A narrative review(5)” gives an excellent overview of the registry.

The utilisation of a pragmatic trial design in combination with a well-established, high-quality registry gives credible scientific results to important questions.

We have previously developed a health-economic model(6) based on data from the registry, which was later adapted to several other countries (7–13). 


1.            Hedberg S, Olbers T, Peltonen M, Österberg J, Wirén M, Ottosson J, et al. BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy. Contemp Clin Trials. 2019 Sep;84:105809.

2.            Hedberg S, Thorell A, Österberg J, Peltonen M, Andersson E, Näslund E, et al. Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 30;7(1):e2353141.

3.            Sundbom M, Näslund I, Näslund E, Ottosson J. High acquisition rate and internal validity in the Scandinavian Obesity Surgery Registry. Surg Obes Relat Dis. 2021 Mar;17(3):606–14.

4.            Tao W, Holmberg D, Näslund E, Näslund I, Mattsson F, Lagergren J, et al. Validation of Obesity Surgery Data in the Swedish National Patient Registry and Scandinavian Obesity Registry (SOReg). Obes Surg. 2016;26(8):1750–6.

5.            Sundbom M, Näslund I, Ottosson J, Stenberg E, Näslund E. Results from the Scandinavian Obesity Surgery Registry: A narrative review. Obes Rev. 2024;25(2):e13662.

6.            Borisenko O, Adam D, Funch-Jensen P, Ahmed AR, Zhang R, Colpan Z, et al. Bariatric Surgery can Lead to Net Cost Savings to Health Care Systems: Results from a Comprehensive European Decision Analytic Model. Obes Surg. 2015 Sep;25(9):1559–68.

7.            Sanchez-Santos R, Padin EM, Adam D, Borisenko O, Fernandez SE, Dacosta EC, et al. Bariatric surgery versus conservative management for morbidly obese patients in Spain: a cost-effectiveness analysis. Expert Rev Pharmacoecon Outcomes Res. 2018 Jun;18(3):305–14.

8.            Borisenko O, Lukyanov V, Johnsen SP, Funch-Jensen P. Cost analysis of bariatric surgery in Denmark made with a decision-analytic model. 2017; Available from: https://ugeskriftet.dk/dmj/cost-analysis-bariatric-surgery-denmark-made-...

9.            Borisenko O, Lukyanov V, Debergh I, Dillemans B. Cost-effectiveness analysis of bariatric surgery for morbid obesity in Belgium. J Med Econ. 2018 Apr;21(4):365–73.

10.         Borisenko O, Mann O, Duprée A. Cost-utility analysis of bariatric surgery compared with conventional medical management in Germany: a decision analytic modeling. BMC Surg [Internet]. 2017 Dec [cited 2018 Apr 19];17(1). Available from: http://bmcsurg.biomedcentral.com/articles/10.1186/s12893-017-0284-0

11.         Lucchese M, Borisenko O, Mantovani LG, Cortesi PA, Cesana G, Adam D, et al. Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling. Obes Facts. 2017;10(3):261–72.

12.         Borisenko O, Burdukova E, Hargreaves J, Adam D, Funch-Jensen P. Cost-Utility of Bariatric Surgery In Belgium, Denmark, and Italy. Value Health. 2015 Nov;18(7):A670–1.

13.         Borisenko O, Lukyanov V, Ahmed AR. Cost–utility analysis of bariatric surgery. 2018;11.