Abstract

Bio-enteric intragastric balloon (BIB) insertion is gaining popularity for weight reduction in obese patients. We evaluated the efficacy, tolerability, and safety of BIB in the treatment of obesity. A total of 173 Saudi obese patients [mean+/-SD age 34.5 +/- 11.6 years, 58 (33.5%) were men] who underwent BIB (InaMed Corporation, California, USA) insertion were followed up clinically, biochemically, and endoscopically for 6-12 months. The mean+/-SD baseline body weight, excess weight, and body mass index (BMI) were 123.5 +/- 39.6 and 68.9 +/- 40.0 kg and 46.7 +/- 14.1 kg/m(2), respectively. Associated dietary control, exercise, and medical treatment were used in 67 (38.7%), 60 (34.7%), and 3 (1.7%), respectively. BIBs were safely and successfully inserted in 15.1 +/- 6.2 min, filled with 626.2 +/- 41.7 ml methylene blue solution, removed after a period of 189.7 +/- 68.3 days, within 14.1 +/- 6.3 min. BIB was not tolerated for 6 months in 33 (19.8%) patients. Body weight and BMI at 6 and 12 months postinsertion were significantly reduced to 112.5 +/- 35.7 kg and 43.1 +/- 13.1 kg/m(2), and 110.7 +/- 34.5 kg and 42.3 +/- 12.6 kg/m(2), respectively (p < 0.01 versus baseline by one-way ANOVA). Furthermore, the mean absolute weight loss and mean percentage excess weight reduction (EWR) at 6 and 12 months post-BIB insertion were 13.5 +/- 13.5 kg and 19.5 +/- 21.8, and 14 +/- 18.5 kg and 18.0 +/- 25.8, respectively. No mortality or major complications has occurred. EWR of >or=25% occurred in 24.1% and 30.1% of patients at 6 and 12 months postinsertion, respectively. BIB is a safe, simple, and potentially efficient procedure that is well-tolerated by the majority of patients.

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