Prospective randomized controlled trial comparing the efficacy and safety of Roux-en-Y gastric bypass and one-anastomosis gastric bypass (the RYSA trial): trial protocol and interim analysis

Tuure Saarinen, Sanna Meriläinen, Vesa Koivukangas, Kirsi Hannele Pietiläinen, Anne Juuti, Tuure Saarinen, Sanna Meriläinen, Vesa Koivukangas, Kirsi Hannele Pietiläinen, Anne Juuti

Abstract

Introduction: There is a lack of prospective studies comparing Roux-en-Y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB). Also, the effects of bariatric surgery and weight loss need a deeper understanding through metabolic studies. We describe the trial protocol and interim analysis of a prospective randomized controlled study comparing RYGB and OAGB: the RYSA trial.

Materials and methods: In total, 120 bariatric patients will be randomized between RYGB and OAGB in two academic centers. All patients will be followed up for 10 years with analysis and measurements of weight, comorbidities, blood tests, body composition and questionnaires. Extensive metabolic analyses (mixed meal tests, energy expenditure, biopsies of muscle and subcutaneous fat, urine, saliva and fecal samples) will be carried out in the Obesity Research Unit, University of Helsinki, for all patients treated at the Helsinki University Hospital (80 patients) at baseline, 6 months and 12 months. Bile reflux will be studied for the OAGB group at the Helsinki University Hospital at 6 months with gastroscopy and scintigraphy.

Results: At an interim analysis at 3 months (half-way) through recruitment (30 RYGB and 30 OAGB patients) there have been no deaths and no intensive care unit admittances. One patient in both groups required additional gastroscopy, with anastomosis dilatation in the RYGB group but with no additional intervention in the OAGB group.

Conclusion: The trial can be safely carried out. Recruitment is estimated to be complete by the end of 2019.

Trial registration: Clinical Trials Identifier NCT02882685. Registered on August 30th 2016.

Keywords: Bariatric surgery; Metabolic surgery; Obesity; One-anastomosis gastric bypass; Roux-en-Y gastric bypass.

Conflict of interest statement

KHP has received grants. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial schedule. DEXA dual-energy x-ray absorptiometry, ECG electrocardiogram, LA Los Angeles (classification), MRI magnetic resonance imaging, SAGB single-anastomosis gastric bypass, V visit
Fig. 2
Fig. 2
Illustration of the Roux-en-Y gastric bypass technique
Fig. 3
Fig. 3
Illustration of the one-anastomosis gastric bypass technique

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