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

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dc.contributor.author Saarinen, Tuure
dc.contributor.author Meriläinen, Sanna
dc.contributor.author Koivukangas, Vesa
dc.contributor.author Pietiläinen, Kirsi H
dc.contributor.author Juuti, Anne
dc.date.accessioned 2020-01-05T04:14:54Z
dc.date.available 2020-01-05T04:14:54Z
dc.date.issued 2019-12-30
dc.identifier.citation Trials. 2019 Dec 30;20(1):803
dc.identifier.uri http://hdl.handle.net/10138/308998
dc.description.abstract 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.
dc.publisher BioMed Central
dc.subject Obesity
dc.subject Bariatric surgery
dc.subject Metabolic surgery
dc.subject Roux-en-Y gastric bypass
dc.subject One-anastomosis gastric bypass
dc.title 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
dc.date.updated 2020-01-05T04:14:54Z
dc.language.rfc3066 en
dc.rights.holder The Author(s).
dc.type.uri http://purl.org/eprint/entityType/ScholarlyWork
dc.type.uri http://purl.org/eprint/entityType/Expression
dc.type.uri http://purl.org/eprint/type/JournalArticle

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