Authors' objectives: To evaluate effectiveness and safety of the intragastric balloon in overweighted and obese patients. Secondary objectives are to design a systematic data-capture process and to perform a retrospective case-registry of intragastric balloon placed in at Galician hospitals between 2004 and 2006 (safety and effectiveness analyses, 2004-2006).

Authors' recommendations: Intragastric balloon seems to be a technique which allows weight reduction in obese patients, although this loss is not kept over time. It should not be used as the first therapeutic option in obese or overweighted patients. The use of a low-calorie diet, physical activity and eating habits modification are first indicated. This technique must be used in combination with other type of interventions (a low-calorie diet, eating habits modification). Those patients who are candidates for surgery could benefit from the fast weight loss due to the intragastric balloon, since the surgical risk diminishes. There are no studies which permit to compare the use of the intragastric balloon with other strategies for weight reduction.This technique is not absolutely safe, reason why patients with intragastric balloon must be correctly informed and monitorised to avoid or minimise complications. It would be important to define the specific indications for the use of the intragastric balloon, which should only be indicated when a fast weight reduction -but limited over time- is needed (reduction of anaesthetic or surgical risk in surgery, either bariatric surgery or any other type). Patients should be carefully selected according to their degree of obesity and comorbidities (BMI≥40 kg/m2 or BMI≥35 kg/m2 with some pathology related to obesity) and also according to the technique contraindications (hiatal hernia, severe esophagitis, gastroduodenal ulcer, previous gastric intervention).Those interventions complementing the procedure should be protocolised (dietetic interventions, psychological support, bariatric surgery). Patients should be adequately informed about benefits and risks of the use of the balloon. The balloon is not recommended to be kept more than six months in order to minimise complications such as balloon breakage or deflation. An active follow-up of patients is proposed to minimise the occurrence of complications and guarantee the balloon withdrawal when expected. The centres where this procedure is made must have well coordinated multidisciplinary working groups for the treatment of obesity. These teams must meet in a periodic way and must make the patients follow-up. They must include endoscopy specialists, experienced in the procedure carrying out, surgeons with experience in obesity surgery, endocrinologists, dieticians and staff forpsychological support (psychologists, psychiatrists).

Project Status: Completed

URL for project: http://www.sergas.es/MostrarContidos_N3_T02.aspx?IdPaxina=60056&uri=http://www.sergas.es/Docs/Avalia-t/InfBalonIntrag.pdf&hifr=900&seccion=0&seccion=0

Year Published: 2007

URL for published report: n/a

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: Galician Agency for Health Technology Assessment (AVALIA-T)