title: Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.
abstract: To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity.
  
  
  
  This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test.
  
  
  
  At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001).
  
  
  
  This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.
authors.affiliation: Department of Surgery, Schön Klinik, Adipositas Zentrum, Fürth, Nürnberg, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Horbach
authors.affiliation: Department of Surgery, Wolfart Klinik, Adipositas Zentrum, München-Graefelfing, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Meyer
authors.affiliation: Departamento de Cirugía, Hospital Virgen del Rocio, Seville, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Morales-Conde
authors.affiliation: Departamento de Cirugía, Hospital Virgen del Rocio, Seville, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Alarcón
authors.affiliation: Department of Surgery, Vicenza Regional Hospital, Vicenza, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Favretti
authors.affiliation: Department of Surgery, University Hospital Pisa, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Anselmino
authors.affiliation: Department of Surgery, Clinica San Luca, Torino, Italy.
authors.forename: G M
authors.initials: GM
authors.lastname: Rovera
authors.affiliation: Department of Surgery, Polyclinique de Rillieux, Clinique Lyon-Nord, Lyon, France.
authors.forename: J
authors.initials: J
authors.lastname: Dargent
authors.affiliation: Department of Surgery, SRH Wald-Klinikum, Adipositas Zentrum, Gera, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Stroh
authors.affiliation: Department of Surgery, C Ev. Krankenhaus Hubertus, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Susewind
authors.affiliation: Department of Surgery, Hospital Clinico San Carlos, Complutense University of Madrid, Madrid, Spain.|Obesity and Metabolic Surgery Department, Hospital Universitario Madrid Monteprincipe, Madrid, Spain.
authors.forename: A J
authors.initials: AJ
authors.lastname: Torres
mesh_terms: D000293:Adolescent; D000328:Adult; D020878:Device Removal; D004599:Electric Stimulation Therapy; D004567:Electrodes, Implanted; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000628:therapy*; D016896:Treatment Outcome; D015431:Weight Loss; D055815:Young Adult