TY  - JOUR
AV  - public
CY  - London
VL  - 15
TI  - 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
Y1  - 2015///
JF  - BMC Surgery
ID  - heidok19391
SP  - 1
IS  - 87
A1  - Fischer, Lars
A1  - Wekerle, Anna-Laura
A1  - Bruckner, Thomas
A1  - Wegener, Inga
A1  - Diener, Markus K.
A1  - Frankenberg, Moritz V.
A1  - Gärtner, Daniel
A1  - Schön, Michael R.
A1  - Raggi, Matthias C.
A1  - Tanay, Emre
A1  - Brydniak, Rainer
A1  - Runkel, Norbert
A1  - Attenberger, Corinna
A1  - Son, Min-Seop
A1  - Türler, Andreas
A1  - Weiner, Rudolf
A1  - Büchler, Markus W.
A1  - Müller-Stich, Beat P.
EP  - 8
SN  - 1471-2482
UR  - https://archiv.ub.uni-heidelberg.de/volltextserver/19391/
N2  - 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
PB  - BioMed Central
ER  -