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 We enrolled 210 patients, of whom 50 were withdrawn preoperatively.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).
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.
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Preparation of the manuscript: Rodolphe Ruffy, MD <www.cardioscript.com> contributed to the composition of the manuscript for style and language and was compensated for his time and efforts. Statistical analysis: independent statistical analysis of study end points by Mark Holdbrook, Senior Advisor, Clinical Affairs, Data Management & Biostatistics for Experien Group. Funding/support: The study was supported by IntraPace Inc., San Jose, CA, USA. Role of the funder/sponsor: IntraPace Inc. was involved in the design and conduct of the study, site selection and database management. The sponsor funded the clinical sites for patient screening, testing, hospitalization, surgery (implant) and database entry. The sponsor funded the independent statistical analysis of the data by Experien Group. Mir Hashim, PhD, Rose Province, MS and Mir Imran, CEO, were sponsor representatives allowed to review and participate in the critical revision of the manuscript before its submission. General data collection and management and study monitoring: Rose Province, MS, Pascal Hellebuyck, CRA; Marianne Kolopp, MD; Ksenija Mlinar, PhD, Javier Sanchez Lopez, Pharm D. Principal Investigator: Thomas Horbach, MD. On-site data collection and management, surgical support and study monitoring: GERMANY Berlin: Julian Gertz, secretary Obesity Center. Gera: Thomas Manger, MD; Anne Zhamn, RN; Sindy Zimmermann, licensed dietitian/nutritionist. München-Graefelfing: Petra Schumann, MD; Jutta Peters, licensed dietitian/nutritionist. Schwabach: Sophie Krüger, MD; Friederike Eschenbacher, licensed dietitian/nutritionist. ITALY Pisa: Carlo Moretto, MD, PhD; Paola Fierabracci, MD; Ferruccio Santini, MD. Vicenza: Gianni Segato, MD; Andrea Ceoloni, MD. Turin: Daniela Delle Piane, MD. Garda–Verona: Dalle Grave, MD, Nutritional and cognitive/behavioral support. SPAIN Madrid: Andrés Sanchez-Pernaute, MD, PhD; Fernando Lapuente, MD; Felipe Acedo, MD, PhD; Antonio Picardo, MD, PhD; Miguel A Rubio MD, PhD; Patricia Sáez MD; Marta Fernandez-Nespral MD. Seville: Maria Socas, MD; Antonio Barranco, MD; Pedro Pablo García-Luna, MD; Jose Luis Pereira MBChB, MSc; Salvador Sobrino, MD.
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Supplementary Information accompanies this paper on International Journal of Obesity website (http://www.nature.com/ijo)