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EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?
Patel, N, Mohanaruban, A, Ashrafian, H, Le Roux, C, Byrne, J, Mason, J, Hopkins, J, Kelly, J, Teare, J
Obesity surgery. 2018;(7):1980-1989
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Abstract
BACKGROUND AND AIMS Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30-50 kg/m2 and HbA1c levels of 7.5-10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. RESULTS Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62-29.38; p < 0.05) and BMI (95%CI 1.1-8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1-1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. CONCLUSIONS The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.
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[Complications of percutaneous endoscopic gastrostomy in the elderly: local skin infection and respiratory infection].
Kanie, J, Kono, K, Kono, T, Osawa, M, Yamamoto, T, Akatsu, H, Shimokata, H, Iguchi, A
Nihon Ronen Igakkai zasshi. Japanese journal of geriatrics. 2000;(2):143-8
Abstract
We investigated post-operative management of acute complications of percutaneous endoscopic gastrostomy (PEG) which often caused respiratory infections and local skin infections. The subjects were a total of 341 patients (male 131, female 210, and the mean age was 80.3), they were classified into six groups by method of feeding and use of antibiotics. Patients were divided into three groups based on the time that feeding was started. In Group I, enteral feeding was not started within the first five days. In Group II, sterilized enteral feeding (lactated Ringer's solution for intravenous infusion) using sterilized intravenous infusion kit started within 24 hours after the procedure, and in Group III, feeding of the usual enteral formula started within 24 hours after the procedure. And as for the using of antibiotics, they were also divided into two groups, antibiotics administered[AB (+)] and no antibiotics administered[AB (-)]. Thus, the patients were divided into six groups according to the time of starting nutrition and the use of antibiotics. The rates of incidence of acute respiratory infections and local skin infections in the six groups were compared by the chi-square test and differences in the rates of incidence of complication were also compared between two PEG methods; the Pull/Push method and the Introducer method. The frequency of local skin infection in Group III was significantly higher than in Group I and Group II. As for the PEG methods, the frequency of local skin infection in the Pull/Push method was significantly higher than Introducer methods. Acute respiratory infections occurred significantly less in the AB (+) group than in the AB (-) group. Postoperative administration of antibiotics would seem to be appropriate for prophylaxis of respiratory infection in elderly patients after PEG. On the other hand, local skin infections are not related to administration of antibiotics, and are highly related to the method of feeding. We concluded that nutrition of sterilized enteral feeding immediately after operation using a sterilized intravenous infusion kit and administration of antibiotics are advisable to prevent major complications in elderly patients.