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

BMC Surgery

Study Protocol

Rudolf Weiner¹  Emre Tanay²  Matthias C. Raggi²  Andreas Türler³  Min-Seop Son³  Rainer Brydniak⁴  Norbert Runkel⁴  Daniel Gärtner⁵  Michael R. Schön⁵  Lars Fischer⁶  Markus W. Büchler⁶  Beat P. Müller-Stich⁶  Anna-Laura Wekerle⁶  Markus K. Diener⁷  Corinna Attenberger⁸  Thomas Bruckner⁹  Moritz V. Frankenberg^1,10  Inga Wegener^1,11 

[1] Department of Bariatric Surgery and Metabolic Surgery, Sana Klinikum Offenbach GmbH, Starkenburgring 66, 63069, Offenbach, Germany;Department of General and Visceral Surgery, Agaplesion Bethesda Krankenhaus Stuttgart, Hohenheimer Straße 21, 70184, Stuttgart, Germany;Department of General and Visceral Surgery, Johanniter Krankenhaus, Johanniter GmbH, Johanniterstraße 3, 53113, Bonn, Germany;Department of General and Visceral Surgery, Schwarzwald- Baar Klinikum, Klinikstraße 11, 78052, Villingen-Schwenningen, Germany;Department of General and Visceral Surgery, Städtisches Krankenhaus Karlsruhe, Moltkestraße 90, 76133, Karlsruhe, Germany;Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany;Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany;Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany;Department of Surgery, Caritas-Krankenhaus St. Josef, Landshuter Straße 65, 93053, Regensburg, Germany;Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany;Salem Hospital, Zeppelinstraße 11 – 33, 69121, Heidelberg, Germany;Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany;

关键词: Sleeve gastrectomy;    Roux-en-Ygastric bypass;    Randomized controlled trial;    Patient and observer blind trial;    Long-term excess weight loss;    Obesity related co-morbidity;    Gastroesophageal reflux disease;    Quality of life;    Morbidity;    Mortality;   

DOI  :  10.1186/s12893-015-0072-7

 received in 2013-11-08, accepted in 2015-07-08,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundRoux-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.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/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.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.

【 授权许可】

CC BY   
© Fischer et al. 2015