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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. [ABSTRACT FROM AUTHOR]

Background: Different anesthesiological techniques are currently used for intragastric balloon positioning and removal. The aim of this study is to compare different anesthesiological approaches for balloon positioning and removal in a large multicentric patient population. Methods: Retrospective multicenter study was conducted. From May 2000 to April 2008, 3,824 patients underwent BIB placement [1,022 male/2,802 female; mean age 39.5 ± 14.7 years, range 12-71 years; mean body mass index (BMI) 44.8 ± 9.7 kg/m, range 28.0-79.1 kg/m; excess weight (EW) 59.1 ± 29.8 kg, range 16-210 kg; %EW 89.3 ± 31.7, range 21.4-262]. Patients were allocated to three groups according to anesthesiological technique used: conscious sedation (group A), deep sedation (group B), and general anesthesia (group C). Intragastric balloon was placed after diagnostic endoscopy and removed after 6 months. Both positioning and removal were done under different protocols. Conscious sedation was obtained with topical lidocaine spray, adding diazepam (0.05-0.1 mg/kg iv) or midazolam (0.03-0.05 mg/kg iv). Deep sedation was obtained with propofol alone or adding other drugs such as midazolam, meperidine/fentanyl or meperidine/fentanyl + midazolam. General anesthesia was obtained with midazolam premedication (0.01-0.02 mg/kg iv) followed by induction with propofol (1-1.5 mg/kg iv) + Norcuron (80 mcg/kg iv) + fentanyl (0.5-1 mcg/kg iv), and maintenance with propofol (50-150 μg/kg/min) or sevorane. Oxygen saturation, hemodynamic stability, major anesthesiological complications and related mortality, patient satisfaction, time to return to autonomous walking, duration of procedure, and hospital stay were considered. Results: Sedation-related mortality was absent. A significant number of patients with bronchoinhalation during balloon removal was observed with general anesthesia ( P < 0.001). Conclusions: BIB positioning and removal should be performed under conscious sedation for patient safety and comfort, and technical success. [ABSTRACT FROM AUTHOR]