Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study
| Autor: | G. M. Rovera, Franco Favretti, G Meyer, M Anselmino, Christine Stroh, M Susewind, J Dargent, Antonio J. Torres, Salvador Morales-Conde, T Horbach, Isaias Alarcón |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Gastric electrical stimulation
Adult Male medicine.medical_specialty Adolescent Gastroplasty Endocrinology Diabetes and Metabolism Medicine (miscellaneous) 030209 endocrinology & metabolism Electric Stimulation Therapy law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Feeding behavior Randomized controlled trial Weight loss law Weight Loss Medicine Humans Adjustable gastric band Device Removal Nutrition and Dietetics business.industry digestive oral and skin physiology Follow up studies Feeding Behavior Middle Aged digestive system diseases Surgery Electrodes Implanted Obesity Morbid Treatment Outcome Multicenter study 030211 gastroenterology & hepatology Female Laparoscopy medicine.symptom business Closed loop Follow-Up Studies |
| Zdroj: | International journal of obesity (2005). 40(12) |
| ISSN: | 1476-5497 |
| Popis: | 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 We enrolled 210 patients, of whom 50 were withdrawn preoperatively.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 mAt 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%; P0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P0.001).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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink