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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Surgery 1/2015

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

Zeitschrift:
BMC Surgery > Ausgabe 1/2015
Autoren:
Lars Fischer, Anna-Laura Wekerle, Thomas Bruckner, Inga Wegener, Markus K. Diener, Moritz V. Frankenberg, 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, Beat P. Müller-Stich
Wichtige Hinweise
Lars Fischer and Anna-Laura Wekerle contributed equally to this work.

Competing interests

The authors hereby declare that they have no competing interests.

Authors’ contributions

All authors contributed to the design of the present study and revised the manuscript critically. All authors read and approved the final manuscript.

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.

Trial registration

The trial protocol has been registered in the German Clinical Trials Register DRKS00004766.
Literatur
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