1. BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35-60 kg/m² - a multi-centre randomized patient and observer blind non-inferiority trial.
- Author
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Fischer, Lars, Wekerle, Anna-Laura, Bruckner, Thomas, Wegener, Inga, Diener, Markus K., Frankenberg, Moritz V., Gärtner, Daniel, Schön, Michael R., Raggi, Matthias C., Tanay, Emre, Brydniak, Rainer, Runkel, Norbert, Attenberger, Corinna, Min-Seop Son, Türler, Andreas, Weiner, Rudolf, Büchler, Markus W., and Müller-Stich, Beat P.
- Subjects
OBESITY treatment ,GASTRECTOMY ,GASTRIC bypass ,BODY mass index ,GASTROESOPHAGEAL reflux ,QUALITY of life ,DISEASE remission - Abstract
Background: Roux-en-Ygastric bypass (RYGB) and sleeve gastrectomy (SG) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation. A systematic review revealed a similar excess weight loss (EWL) 2 years postoperatively between SG and RYGB. However, there is a lack of randomized controlled multi-centre trials comparing SG and RYGB, not only concerning EWL, but also in terms of remission of obesity-related co-morbidities, gastroesophageal reflux disease (GERD) and quality of life (QoL) in the mid- and long-term. Methods: The BariSurg trial was designed as a multi-centre, randomized controlled patient and observer blind trial. The trial protocol was approved by the corresponding ethics committees of the centres. To demonstrate EWL non-inferiority of SG compared to RYGB, power calculation was performed according to a non-inferiority study design. Morbidity, mortality, remission of obesity-related co-morbidities, GERD course and QoL are major secondary endpoints. 248 patients between 18 and 70 years, with a body mass index (BMI) between 35-60 kg/m² and indication for bariatric surgery according to the most recent German S3-guidelines will be randomized. The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3-6, 12, 24, 36, 48 and 60 months postoperatively. Discussion: With its five year follow-up, the BariSurg-trial will provide further evidence based data concerning the impact of SG and RYGB on EWL, remission of obesity-related co-morbidities, the course of GERD and QoL. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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