BACKGROUND: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.
BACKGROUND:Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obesepatients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.
Authors: A Genco; T Bruni; S B Doldi; P Forestieri; M Marino; L Busetto; C Giardiello; L Angrisani; L Pecchioli; P Stornelli; F Puglisi; M Alkilani; A Nigri; N Di Lorenzo; F Furbetta; A Cascardo; M Cipriano; M Lorenzo; N Basso Journal: Obes Surg Date: 2005-09 Impact factor: 4.129
Authors: Anne Berghöfer; Tobias Pischon; Thomas Reinhold; Caroline M Apovian; Arya M Sharma; Stefan N Willich Journal: BMC Public Health Date: 2008-06-05 Impact factor: 3.295