Abstract
Background
The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance.
Methods
Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon–BIB; n = 30; 20 F/10 M, mean age 36.7 ± 10.9; mean BMI 46.5 ± 5.9) and group B (Endobag-Heliosphere; n = 30; 20 F/10 M, mean age 37.8 ± 10.6; mean BMI 46.1 ± 5.6). All patients of both groups were sedated with midazolam (5 mg) + Propofol (2 mg/kg i.v.). The Heliosphere Bag was air-filled with 950 ml while BIB® was inflated with 500 ml of saline and 10 ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and χ 2 test were used for statistical analysis.
Results
Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8 ± 6.2 and 41.9 ± 6.5(p = ns), and mean %EWL was 20 ± 12 and 18 ± 14 (p = ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx.
Conclusions
Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.
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References
Imaz I, Martinez-Cervell C, Garcia-Alvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18:841–6.
Genco A, Cipriano M, Bacci V, et al. Bioenterics Intragastric Balloon (BIB): a double blind, randomised, controlled, cross-over study. Int J Obes. 2006;30:129–3.
Dumonceau LM. Evidence based review of the Bioenterics Intragastric Balloon for weight loss. Obes Surg. 2008;18:1611–7.
Angrisani L, Lorenzo M, Borrelli V, et al. Is bariatric surgery necessary after intragastric balloon treatment? Obes Surg. 2006;16:1135–7.
Weiner A, Gutberlet H, Bockhorn H. Preparation of extremely obese patients for laparoscopic gastric banding by gastric balloon therapy. Obes Surg. 1999;9(3):261–4.
De Waele B, Reynaert H, Urbain D, et al. Intragastric balloons for preoperative weight reduction. Obes Surg. 2000;10(1):58–60.
Melissas J, Mouzas J, Filis D, et al. The intragastric balloon—smoothing the path to bariatric surgery. Obes Surg. 2006;16:897–902.
Forestieri P, De Palma GD, Formato A, et al. Heliosphere bag in the treatment of severe obesity: preliminary experience. Obes Surg. 2006;16:635–7.
Mion F, Gincul R, Roman S, et al. Tolerance and efficacy of an air filled balloon in non-morbidly obese patients: results of a prospective multicenter study. Obes Surg. 2007;17:764–9.
De Castro ML, Morales MJ, Del Campo V, et al. Efficacy, safety and tolerance of two types of intragastric balloons placed in obese subjects: a double blind comparative study. Obes Surg. 2010;20:1642–6.
NIH Conference. Gastrointestinal surgery for severe obesity. Consensus development conference panel. Ann Intern Med. 1991;115:956–61.
Genco A, Bruni T, Doldi SB, et al. BioEnterics Intragastric balloon: the Italian experience with 2,515 patients. Obes Surg. 2005;15:1161–4.
Lison L. Tavole numeriche. In: Lison L, editor. Statistica Applicata. Milano Ed It; 1986. p. 272–3
Nieben OG, Harboe H. Intragatric balloon as an artificial bezoar for treatment of obesity. Lancet. 1982;1:198–9.
McFarland RJ, Grundy A, Gazet JC, et al. The intragastric balloon: a novel idea proved ineffective. Br J Surg. 1987;74:137–9.
Ramhamadany EM, Fowler J, Baird IM. Effect of the gastric balloon versus sham procedure on weight loss in obese subjects. Gut. 1989;30:1054–7.
Benjamin SB, Maher KA, Cattau EL, et al. Double blind controlled trial of the Garren-Edward gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology. 1988;95:581–8.
Hogan RB, Johnston JH, Long BW, et al. A double blind, randomised, sham controlled trial of the gastric bubble for obesity. Gastrointest Endosc. 1989;35:381–5.
Meshkinpour H, Hsu D, Farivar S. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology. 1988;95:589–92.
Mathus-Vliegen EMH, Tytgat GNJ. Intragastric balloon for the morbid obesity: results, patients toleranceand balloon life-span. Br J Surg. 1990;77:77–9.
Schapiro M, Benjamin S, Blackburn G, et al. Obesity and the gastric balloon: a comprehensive workshop. Tarpon springs, Florida, March 19–21, 1987. Gatrointest Endosc. 1987;33: 323–7
Genco A, Cipriano M, Bacci V, et al. Intragastric balloon followed by diet vs intragastric balloon followed by another balloon. A prospective study on 100 patients. Obes Surg. 2010;20(11):1096–10.
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Giardiello, C., Borrelli, A., Silvestri, E. et al. Air-Filled vs Water-Filled Intragastric Balloon: a Prospective Randomized Study. OBES SURG 22, 1916–1919 (2012). https://doi.org/10.1007/s11695-012-0786-x
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DOI: https://doi.org/10.1007/s11695-012-0786-x