Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial

Trials
Marko KraljevićUrs Zingg

Abstract

Laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the gold standard in bariatric surgery, achieving durable long-term weight loss with improvement of obesity-related comorbidities. Lately, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity with similar results to LRYGB in terms of weight loss and comorbidity resolution. However, there is a lack of randomized controlled trials (RCT) comparing LMGB and LRYGB. This article describes the design and protocol of a randomized controlled trial comparing the outcomes of these two bariatric procedures. The trial is designed as a single center, randomized, patient and observer blinded trial. The relevant ethics committee has approved the trial protocol. To demonstrate that LMGB is not inferior to LRYGB in terms of excess weight loss (EWL) the study is conducted as a non-inferiority trial with the sample-size calculations performed accordingly. EWL 12 months after surgery is the primary endpoint, whereas 3-year EWL, morbidity, mortality, remission of obesity related comorbidities, quality of life (QOL) and hormonal and lipid profile changes are secondary endpoints. Eighty patients, 18 years or older and with a body mass index (BMI) between 35 and 50 kg/m2...Continue Reading

Associated Clinical Trials

References

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Citations

Jun 23, 2018·Der Chirurg; Zeitschrift für alle Gebiete der operativen Medizen·S Chiappetta, R Weiner
Jul 5, 2019·International Journal of Obesity : Journal of the International Association for the Study of Obesity·Erika TarascoThomas A Lutz
Jan 27, 2021·Heart Failure Reviews·Tanuka DattaDavid J Whellan

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Methods Mentioned

BETA
gastric bypass

Clinical Trials Mentioned

NCT02601092

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