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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.
Fischer, Lars; Wekerle, Anna-Laura; Bruckner, Thomas; Wegener, Inga; Diener, Markus K; Frankenberg, Moritz V; Gärtner, Daniel; Schön, Michael R; Raggi, Matthias C; Tanay, Emre; Brydniak, Rainer; Runkel, Norbert; Attenberger, Corinna; Son, Min-Seop; Türler, Andreas; Weiner, Rudolf; Büchler, Markus W; Müller-Stich, Beat P.
Afiliación
  • Fischer L; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. lars.fischer@med.uni-heidelberg.de.
  • Wekerle AL; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
  • Bruckner T; Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany.
  • Wegener I; Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
  • Diener MK; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
  • Frankenberg MV; Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
  • Gärtner D; Salem Hospital, Zeppelinstraße 11 - 33, 69121, Heidelberg, Germany.
  • Schön MR; Department of General and Visceral Surgery, Städtisches Krankenhaus Karlsruhe, Moltkestraße 90, 76133, Karlsruhe, Germany.
  • Raggi MC; Department of General and Visceral Surgery, Städtisches Krankenhaus Karlsruhe, Moltkestraße 90, 76133, Karlsruhe, Germany.
  • Tanay E; Department of General and Visceral Surgery, Agaplesion Bethesda Krankenhaus Stuttgart, Hohenheimer Straße 21, 70184, Stuttgart, Germany.
  • Brydniak R; Department of General and Visceral Surgery, Agaplesion Bethesda Krankenhaus Stuttgart, Hohenheimer Straße 21, 70184, Stuttgart, Germany.
  • Runkel N; Department of General and Visceral Surgery, Schwarzwald- Baar Klinikum, Klinikstraße 11, 78052, Villingen-Schwenningen, Germany.
  • Attenberger C; Department of General and Visceral Surgery, Schwarzwald- Baar Klinikum, Klinikstraße 11, 78052, Villingen-Schwenningen, Germany.
  • Son MS; Department of Surgery, Caritas-Krankenhaus St. Josef, Landshuter Straße 65, 93053, Regensburg, Germany.
  • Türler A; Department of General and Visceral Surgery, Johanniter Krankenhaus, Johanniter GmbH, Johanniterstraße 3, 53113, Bonn, Germany.
  • Weiner R; Department of General and Visceral Surgery, Johanniter Krankenhaus, Johanniter GmbH, Johanniterstraße 3, 53113, Bonn, Germany.
  • Büchler MW; Department of Bariatric Surgery and Metabolic Surgery, Sana Klinikum Offenbach GmbH, Starkenburgring 66, 63069, Offenbach, Germany.
  • Müller-Stich BP; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
BMC Surg ; 15: 87, 2015 Jul 18.
Article en En | MEDLINE | ID: mdl-26187377
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 .
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Obesidad Mórbida / Derivación Gástrica / Gastrectomía Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Aspecto: Ethics / Patient_preference Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: BMC Surg Año: 2015 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Obesidad Mórbida / Derivación Gástrica / Gastrectomía Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Aspecto: Ethics / Patient_preference Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: BMC Surg Año: 2015 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido