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.

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 .

Short-term ischemia usually used for ischemic preconditioning causes loss of dendritic integrity after long-term survival in the gerbil hippocampus.

Ischemic preconditioning has been established as a powerful experimental neuroprotective strategy, both after global and focal cerebral ischemia. Little is known, however, about the structural and functional long-term outcome. Therefore, our present study was designed to check for potential subtle alterations in the hippocampus after long-term survival. Gerbils were subjected either to short-term ischemia of 2.5 min duration usually used for ischemic preconditioning (n=8) or to sham operation (n=6) and allowed to survive for 6 weeks. Hippocampi with neuronal densities comparable to those of sham-operated control animals were analyzed for dendritic marker proteins MAP2, MAP1B and synaptopodin, respectively. Although MAP2 immunoreactivity was widely unchanged in all hippocampal subfields, both MAP1B and synaptopodin protein expression was decreased to about 80% to 90% of sham controls. A significant reduction, however, was only seen for synaptopodin immunoreactivity in stratum oriens and pyramidale of hippocampal CA1 subfield. In conclusion, our data indicate a dissociation of neuronal survival and dendritic integrity 6 weeks after short-term ischemia usually used for ischemic preconditioning. Analysis of postischemic synaptopodin protein expression is the most sensitive method to detect subtle dendritic changes compared to the classical dendritic marker molecules MAP2 and MAP1B.