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Obesity Surgery
Published in: Obesity Surgery 2/2013

Open Access 01-02-2013 | Clinical Report

3-Year Real-World Outcomes with the Swedish Adjustable Gastric Band™ in France

Authors: G. Ribaric, J. N. Buchwald, G. d’Orsay, F. Daoud, for the French Health Technology Assessment Body (Haute Autorité de Santé [HAS]) Swedish Adjustable Gastric Band (SAGB™) Study Group

Published in: Obesity Surgery | Issue 2/2013

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Abstract

The study objective was to ascertain outcomes with the Swedish adjustable gastric band (SAGB) on an intention-to-treat basis in multiple centers across the French social health insurance system. SAGB results at 3-year follow-up are reported. The noncomparative, observational, prospective, consecutive cohort study design sought a 500-patient minimum recruitment geographically representative of continental France. Safety (adverse events [AEs], device-related morbidity, and mortality) and effectiveness (change in body mass index [BMI, kilograms per square meter], percentage excess weight loss, comorbidities, quality of life [QoL]) were assessed. Adjustable gastric band survival was calculated. Thirty-one surgeons in 28 multidisciplinary teams/sites enrolled patients between September 2, 2007 and April 30, 2008. SAGB was successfully implanted in 517 patients: 88.0 % female; mean age, 37.5 years; obesity duration, 15.3 years (baseline: mean BMI, 41.0; comorbidities, 773 in 74.3 % of patients; Bariatric Analysis and Reporting Outcome System (BAROS), 1.4; EuroQoL 5-Dimensions (EQ-5D), 0.61; EuroQoL–visual analog scale (EQ–VAS), 52.3). At 3 years: BMI, 32.2 (mean change, −9.0; p < 0.0001); excess weight loss, 47.4 %; comorbidities, 161 in 27.2 %; BAROS, 3.6 (+2.2, p < 0.0001); EQ-5D, 0.84 (+0.22, p < 0.0001); EQ–VAS, 73.4 (+21.4, p < 0.0001). SAGB-induced weight loss was associated with substantially improved QoL. One death occurred and was unrelated to the treatment. No AE was reported in 68.3 % of patients, and no confirmed device-related AE in 77.0 %. Overall AE rate was 0.19 per patient year. Device retention was 87.0 %. Analysis of patients lost to follow-up showed a nonsignificant effect on overall study results. In a prospective, consecutive cohort, “real-world”, nationwide study, the Swedish Adjustable Gastric Band was found safe and effective at 3-year follow-up.
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Metadata
Title
3-Year Real-World Outcomes with the Swedish Adjustable Gastric Band™ in France
Authors
G. Ribaric
J. N. Buchwald
G. d’Orsay
F. Daoud
for the French Health Technology Assessment Body (Haute Autorité de Santé [HAS]) Swedish Adjustable Gastric Band (SAGB™) Study Group
Publication date
01-02-2013
Publisher
Springer-Verlag
Published in
Obesity Surgery / Issue 2/2013
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-012-0765-2

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