T Horbach1, G Meyer2, S Morales-Conde3, I Alarcón3, F Favretti4, M Anselmino5, G M Rovera6, J Dargent7, C Stroh8, M Susewind9, A J Torres10,11. 1. Department of Surgery, Schön Klinik, Adipositas Zentrum, Fürth, Nürnberg, Germany. 2. Department of Surgery, Wolfart Klinik, Adipositas Zentrum, München-Graefelfing, Germany. 3. Departamento de Cirugía, Hospital Virgen del Rocio, Seville, Spain. 4. Department of Surgery, Vicenza Regional Hospital, Vicenza, Italy. 5. Department of Surgery, University Hospital Pisa, Pisa, Italy. 6. Department of Surgery, Clinica San Luca, Torino, Italy. 7. Department of Surgery, Polyclinique de Rillieux, Clinique Lyon-Nord, Lyon, France. 8. Department of Surgery, SRH Wald-Klinikum, Adipositas Zentrum, Gera, Germany. 9. Department of Surgery, C Ev. Krankenhaus Hubertus, Berlin, Germany. 10. Department of Surgery, Hospital Clinico San Carlos, Complutense University of Madrid, Madrid, Spain. 11. Obesity and Metabolic Surgery Department, Hospital Universitario Madrid Monteprincipe, Madrid, Spain.
Abstract
OBJECTIVE: 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. METHODS: 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 We enrolled 210 patients, of whom 50 were withdrawn preoperatively.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 receivedCLGES 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. RESULTS: 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). CONCLUSIONS AND RELEVANCE: 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.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS AND RELEVANCE: 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: Scott A Shikora; Richard Bergenstal; Marc Bessler; Fred Brody; Gary Foster; Arthur Frank; Mark Gold; Samuel Klein; Robert Kushner; David B Sarwer Journal: Surg Obes Relat Dis Date: 2008-10-01 Impact factor: 4.734
Authors: Aram V Chobanian; George L Bakris; Henry R Black; William C Cushman; Lee A Green; Joseph L Izzo; Daniel W Jones; Barry J Materson; Suzanne Oparil; Jackson T Wright; Edward J Roccella Journal: Hypertension Date: 2003-12-01 Impact factor: 10.190
Authors: Scott A Cunneen; Collin E M Brathwaite; Christopher Joyce; Keith Gersin; Keith Kim; Jon L Schram; Erik B Wilson; Michael Schwiers; Mario Gutierrez Journal: Surg Obes Relat Dis Date: 2013-03-14 Impact factor: 4.734
Authors: David Arterburn; Andy Bogart; Karen J Coleman; Sebastien Haneuse; Joe V Selby; Nancy E Sherwood; Stephen Sidney; Mary Kay Theis; Guilherme M Campos; David McCulloch; Patrick J O' Connor Journal: Obes Res Clin Pract Date: 2013 Jul-Aug Impact factor: 2.288
Authors: I Alarcón Del Agua; M Socas-Macias; L Busetto; A Torres-Garcia; A Barranco-Moreno; P P Garcia de Luna; S Morales-Conde Journal: Obes Surg Date: 2017-06 Impact factor: 4.129
Authors: S Morales-Conde; I Alarcón Del Agua; L Busetto; F Favretti; M Anselmino; G M Rovera; M Socas-Macias; A Barranco-Moreno; R Province-Azalde; A J Torres Journal: Obes Surg Date: 2018-06 Impact factor: 4.129
Authors: Arjun K Fontaine; Gregory L Futia; Pradeep S Rajendran; Samuel F Littich; Naoko Mizoguchi; Kalyanam Shivkumar; Jeffrey L Ardell; Diego Restrepo; John H Caldwell; Emily A Gibson; Richard F Ff Weir Journal: Sci Rep Date: 2021-02-11 Impact factor: 4.379