• Bmc Surg · Jul 2015

    Randomized Controlled Trial Multicenter Study

    BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35-60 kg/m(2) - a multi-centre randomized patient and observer blind non-inferiority trial.

    • Lars Fischer, Anna-Laura Wekerle, Thomas Bruckner, Inga Wegener, Markus K Diener, Frankenberg Moritz V MV Salem Hospital, Zeppelinstraße 11 - 33, 69121, Heidelberg, Germany., Daniel Gärtner, Michael R Schön, Matthias C Raggi, Emre Tanay, Rainer Brydniak, Norbert Runkel, Corinna Attenberger, Min-Seop Son, Andreas Türler, Rudolf Weiner, Markus W Büchler, and Beat P Müller-Stich.
    • Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. lars.fischer@med.uni-heidelberg.de.
    • Bmc Surg. 2015 Jul 18; 15: 87.

    BackgroundRoux-en-Y gastric 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.MethodsThe 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/m(2) 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.DiscussionWith 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.Trial RegistrationThe trial protocol has been registered in the German Clinical Trials Register DRKS00004766 .

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