Obesity Treatment Using a Bioenterics Intragastric Balloon (BIB)-Preliminary Croatian Results

Department of Internal Medicine, Gastroenterology and Hepatology Division, University Hospital Sestre Milosrdnice, Zagreb, Croatia.
Obesity Surgery (Impact Factor: 3.75). 03/2010; 21(8):1305-10. DOI: 10.1007/s11695-010-0101-7
Source: PubMed


This study aims to assess the effectiveness, tolerance, safety, and patient satisfaction of obesity treatments using the Bioenterics intragastric balloon (BIB).
Prospective controlled trial of 33 obese patients who were treated with the BIB from March 2008 to March 2009 and who completed the 6 months treatment. Patients were selected on the basis of workup by a multidisciplinary team. The 33 obese patients (26 females, seven males) had a median age of 35 years (range 20-58). Their median baseline body weight (BW) was 114 kg (range 89-197) and their median body mass index (BMI) was 41.4 kg/m(2) (range 31.2-60.8).
Average weight reduction was 14 kg (range 2-37), loss total weight 10.1% (range 1.4-23.1), control BMI 35.6 kg/m(2) (range 29.4-50.3), delta BMI 4.5 (range 0.6-13.1), percentage excess weight loss 29.2 (range 2.8-53.6), and percent of excess BMI loss 29.3 (range 2.7-67.4). In one female patient the BIB was removed early due to intolerance. During the first week, minor side effects were noticed: nausea/vomiting occurred in 21 patients (63.6%), and abdominal cramps in 15 (45.5%). There was one balloon deflation and one impaction in the stomach. Those incidents were both successfully treated endoscopically. Patients had no major complications from mucosal lesions and no need for surgical interventions. All intragastric balloons were successfully removed endoscopically. Patients' treatment satisfaction correlated with the degree of BW loss (p = 0.0138).
BIB treatment in our setting showed the best results for individuals with BMI from 35 to 40 kg/m(2). Our preliminary results showed that BIB is safe, well tolerated with minor side effects, and alters quality of life for the better. The complication rate was negligible, due to the detailed pretreatment examinations and follow-up.

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    • "The most examined and widely used BioEnterics Intragastric Balloon (BIB) (Allergan Inc., Irvine, CA, USA) is usually inflated with 500 to 700 mL saline/methylene blue solution. The significant weight of the devices provokes abdominal pain or cramps, nausea, and vomiting [13, 48] which are reported to be the most common adverse events. Alternatively, air-filled polyurethane/silicone heliosphere balloon (HB) (Heliosphere BAG; Helioscopie, Vienne, France) has been designed (weighing only 30 g) to overcome the BIB's heaviness and the associated necessity for early removal. "
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    ABSTRACT: GROWING WORLDWIDE OBESITY EPIDEMIC HAS PROMPTED THE DEVELOPMENT OF TWO MAIN TREATMENT STREAMS: (a) conservative approaches and (b) invasive techniques. However, only invasive surgical methods have delivered significant and sustainable benefits. Therefore, contemporary research exploration has focused on the development of minimally invasive gastric manipulation methods featuring a safe but reliable and long-term sustainable weight loss effect similar to the one delivered by bariatric surgeries. This antiobesity approach is based on placing external devices in the stomach ranging from electrodes for gastric electrical stimulation to temporary intraluminal bezoars for gastric volume displacement for a predetermined amount of time. The present paper examines the evolution of these techniques from invasively implantable units to completely noninvasive patient-controllable implements, from a functional, rather than from the traditional, parametric point of view. Comparative discussion over the available pilot and clinical studies related to gastric electrical stimulation outlines the promises and the fallacies of this concept as a reliable alternative anti-obesity strategy.
    Full-text · Article · Feb 2013
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    • "The first was a case of gastric perforation due to balloon insertion which made the patient refer to the emergency department with severe abdominal pain within 24 hours of the procedure, both patients had the same symptoms and history. Due to the growing prevalence of obesity and the use of modalities such as intragastric balloons as well as their side effects, abdominal pain in an obese patient with a history of balloon insertion constitutes a diagnostic challenge because the majority of the reported complications, ranging from benign to life threatening, can present with abdominal pain and nausea or vomiting [5, 6, 10–16] (Table 2). Therefore, when the diagnosis is in doubt, performing an endoscopy and abdominal ultrasound imaging seems to be a reasonable step. "
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    ABSTRACT: We report a 25-year-old man with small bowel obstruction due to migration of a saline-filled intragastric balloon before the completion of the recommended 6 months of treatment who presented to the emergency department with abdominal pain. The patient had received a gastric balloon insertion 5 months prior. Within 24 hours of the original procedure, he noticed urine staining. The results of an endoscopy conducted the next day were normal. After ruling out other possible complications using endoscopy and confirming the diagnosis by computed tomography (CT) scan and conservative treatment for 48 hours the patient underwent surgery and the balloon was extracted. Due to the growing prevalence of obesity and the modalities used for treating it, physicians should be familiar with the side effects of each option and their presenting symptoms as well as the differential diagnosis they should not miss. Physicians must also improve their knowledge of how to approach these patients to avoid life-threatening complications caused by these modalities.
    Full-text · Article · Oct 2012 · Case Reports in Medicine
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    ABSTRACT: Ghrelin and leptin recently emerged as the most influential neuroendocrine factors in the pathophysiology of obesity. The said peptides act in reciprocity and are responsible for regulation of appetite and energy metabolism. Intragastric balloons acquired worldwide popularity for obesity treatment. However, the roles of ghrelin and leptin in intragastric balloon treatment were still not systematically studied. A prospective single-center study included 43 Caucasians treated with BioEnterics intragastric balloon, with age range of 18-60, and divided to non-morbid (body mass index cutoff 40 kg/m(2)) or morbid type of obesity, with 12 months follow-up. Serum hormonal samples were taken from fasting patients and kept frozen until analyses. Significant differences were observed in anthropometrics and there were no differences between genders or comorbidities. The baseline weight for non-morbid vs. morbid was 104 kg (90-135) vs. 128.5 kg (104-197). Weight loss was statistically different between the studied groups during the study course with a median control weight at 6 months of 92 kg (72-121) vs. 107 kg (84-163), p < 0.001. Treatment was successful for 18 (94.7%) vs. 16 (66.7%) patients, p = 0.026. Ghrelin varied from 333.3 to 3,416.8 pg/ml and leptin from 1.7 to 61.2 ng/ml, with a statistically significant time-dependent relationship. A significant difference (p = 0.04) with emphasized ghrelin peak was found in the 3rd month of treatment for non-morbidly obese subjects. The importance of ghrelin and leptin in treatment-induced changes was reaffirmed. Ghrelin hyper-response in non-morbidly obese subjects characterized greater short-term treatment efficiency and landmarked an inclination to weight regain. The results suggest a potential pattern of individualization between obese patients according to body mass index towards intragastric balloon or bariatric surgery. Further studies are needed in order to get better insights in the pathophysiologic mechanisms of obesity.
    No preview · Article · Apr 2011 · Obesity Surgery
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