title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial protocol has been registered in the German Clinical Trials Register DRKS00004766 .
authors.affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. lars.fischer@med.uni-heidelberg.de.
authors.forename: Lars
authors.initials: L
authors.lastname: Fischer
authors.affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
authors.forename: Anna-Laura
authors.initials: AL
authors.lastname: Wekerle
authors.affiliation: Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.affiliation: Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
authors.forename: Inga
authors.initials: I
authors.lastname: Wegener
authors.affiliation: 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.
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.affiliation: Salem Hospital, Zeppelinstraße 11 - 33, 69121, Heidelberg, Germany.
authors.forename: Moritz V
authors.initials: MV
authors.lastname: Frankenberg
authors.affiliation: Department of General and Visceral Surgery, Städtisches Krankenhaus Karlsruhe, Moltkestraße 90, 76133, Karlsruhe, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Gärtner
authors.affiliation: Department of General and Visceral Surgery, Städtisches Krankenhaus Karlsruhe, Moltkestraße 90, 76133, Karlsruhe, Germany.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Schön
authors.affiliation: Department of General and Visceral Surgery, Agaplesion Bethesda Krankenhaus Stuttgart, Hohenheimer Straße 21, 70184, Stuttgart, Germany.
authors.forename: Matthias C
authors.initials: MC
authors.lastname: Raggi
authors.affiliation: Department of General and Visceral Surgery, Agaplesion Bethesda Krankenhaus Stuttgart, Hohenheimer Straße 21, 70184, Stuttgart, Germany.
authors.forename: Emre
authors.initials: E
authors.lastname: Tanay
authors.affiliation: Department of General and Visceral Surgery, Schwarzwald- Baar Klinikum, Klinikstraße 11, 78052, Villingen-Schwenningen, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Brydniak
authors.affiliation: Department of General and Visceral Surgery, Schwarzwald- Baar Klinikum, Klinikstraße 11, 78052, Villingen-Schwenningen, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Runkel
authors.affiliation: Department of Surgery, Caritas-Krankenhaus St. Josef, Landshuter Straße 65, 93053, Regensburg, Germany.
authors.forename: Corinna
authors.initials: C
authors.lastname: Attenberger
authors.affiliation: Department of General and Visceral Surgery, Johanniter Krankenhaus, Johanniter GmbH, Johanniterstraße 3, 53113, Bonn, Germany.
authors.forename: Min-Seop
authors.initials: MS
authors.lastname: Son
authors.affiliation: Department of General and Visceral Surgery, Johanniter Krankenhaus, Johanniter GmbH, Johanniterstraße 3, 53113, Bonn, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Türler
authors.affiliation: Department of Bariatric Surgery and Metabolic Surgery, Sana Klinikum Offenbach GmbH, Starkenburgring 66, 63069, Offenbach, Germany.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Weiner
authors.affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
authors.forename: Beat P
authors.initials: BP
authors.lastname: Müller-Stich
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy; D015390:Gastric Bypass; D005764:Gastroesophageal Reflux / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery; D009767:Obesity, Morbid / Q000150:complications / Q000601:surgery*; D011788:Quality of Life; D016896:Treatment Outcome; D015431:Weight Loss; D055815:Young Adult