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

BMC Surgery

Beat P. Müller-Stich¹  Markus W. Büchler¹  Rudolf Weiner²  Andreas Türler⁵  Min-Seop Son⁵  Corinna Attenberger⁷  Norbert Runkel⁹  Rainer Brydniak⁹  Emre Tanay⁸  Matthias C. Raggi⁸  Michael R. Schön⁴  Daniel Gärtner⁴  Moritz V. Frankenberg³  Markus K. Diener⁶  Inga Wegener⁶  Thomas Bruckner^1,10  Anna-Laura Wekerle¹  Lars Fischer¹ 

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

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

Others  :  1219811
DOI  :  10.1186/s12893-015-0072-7

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

【 摘 要 】

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/m ²and 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.

【 授权许可】

   
2015 Fischer et al.

【 图 表 】

Figure 1.

Fig. 2.

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