Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.

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 We enrolled 210 patients, of whom 50 were withdrawn preoperatively.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.

[Nutritional deficiencies and supplementation after metabolic surgery]. / Nutritive Defizite und Supplementation nach metabolischer Chirurgie.

Increasing prevalence of morbid obesity in Germany is associated with an increasing number of bariatric surgical interventions.Based on the effectiveness of bariatric surgery with regard to a significant reduction of body weight and comorbidity as well as improvement of the quality of life compared with conservative measures, its value and impact has been substantially increased. Long-term metabolic deficits such as nutrient deficiencies can be considered the main risks of various restrictive, combined and malabsorptive procedures of bariatric surgery.The aim of this overview is to characterize metabolic complications after bariatric surgery and their prophylaxis, which require a temporary or permanent surveillance and, if necessary, effective supplementation.Bariatric surgical interventions such as gastric banding (GB) and sleeve gastrectomy (SG) can be subsequently associated with deficiencies related to B­vitamins whereas iron, folate, and vitamins B1, B12 and D deficiencies might be consequences of malabsorptive procedures such as biliopancreatic diversion, duodenal switch and Roux-en-Y gastric bypass.Due to possible metabolic and surgical complications after bariatric surgery, patients need to undergo life-long follow-up investigations. The currently available guidelines of the American Association of Bariatric and Metabolic Surgery are the basis for the latest recommendations on supplementation and treatment in bariatric surgery.

[Nutrient Deficiencies after Bariatric Surgery - Systematic Literature Review and Suggestions for Diagnostics and Treatment]. / Nutritive Defizite nach bariatrischer Chirurgie - systematische Literaturanalyse und Empfehlungen für Diagnostik und Substitution.

The increasing prevalence of morbid obesity in Germany is associated with an increasing number of metabolic surgical interventions. Short-term surgical and long-term metabolic complications such as nutrient deficiencies can be considered the main risks of metabolic surgery and its restrictive and malabsorbant surgical procedures. The aim of this compact short overview based on a selective literature search and our own clinical experience is to characterise the long-term metabolic complications, which are specific for the various bariatric procedures, and to refine the published guidelines for supplementation. Restrictive bariatric procedures can be associated with well-known surgical problems such as pouch dilatation or band migration, e.g., after gastric banding. After sleeve gastrectomy, emerging reflux disease can become a substantial problem. The most frequent deficiencies after restrictive procedures are related to B-vitamins whereas iron, folate, vitamin B1 and B12 and vitamin D deficiencies are associated with the malabsorptive procedure such as biliopancreatic diversion, duodenal switch and Roux-en-Y gastric bypass. Due to possible metabolic and surgical complications after bariatric surgery, patients need to undergo life-long medical follow-up investigations. The currently available guidelines of German Society of Treatment of Obesity (CAADIP) of DGAV for supplementation should be known and followed, in particular, by the physicians who i) are exceptionally involved in medical care of obese people and ii) do it in full awareness of the obligatory postoperative clinical observation.