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Randomized Controlled Trial
. 2015 Jul 18:15:87.
doi: 10.1186/s12893-015-0072-7.

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  1 , Anna-Laura Wekerle  2 , Thomas Bruckner  3 , Inga Wegener  4 , Markus K Diener  2   4 , Moritz V Frankenberg  5 , Daniel Gärtner  6 , Michael R Schön  6 , Matthias C Raggi  7 , Emre Tanay  7 , Rainer Brydniak  8 , Norbert Runkel  8 , Corinna Attenberger  9 , Min-Seop Son  10 , Andreas Türler  10 , Rudolf Weiner  11 , Markus W Büchler  2 , Beat P Müller-Stich  2
Affiliations
Randomized Controlled Trial

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 et al. BMC Surg. .

Abstract

Background: Roux-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.

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/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.

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.

Trial registration: The trial protocol has been registered in the German Clinical Trials Register DRKS00004766 .

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Figures

Fig. 1
Fig. 1
Flow chart of BariSurg trial, showing the timeline and the course for trial participants. Abbreviations: BMI: body mass index, T2DM: type 2 diabetes mellitus, EWL: excess weight loss, EGD: esophagogastroduodenoscopy, SF-36: Short-Form-36 Health Survey, GIQLI: gastrointestinal quality of life index, GSRS: gastrointestinal symptom rate score, EWL: excess weight loss, GERD: gastroesphageal reflux disease
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