Abstract
Background
The BioEnterics® Intragastric Balloon (BIB®) is a well-established device for temporary treatment in morbidly obese patients. The aim of this study is the evaluation, in a population of 714 consecutive outpatient setting cases, BIB® results in terms of weight loss and comorbidity change.
Methods
BIB® was positioned in all cases after diagnostic endoscopy. The device was inflated under direct endoscopic vision with saline solution (600–700 ml) and methylene blue (10 ml). Intubation was carried out in patients with body mass index (BMI) > 40 kg/m2 affected by sleep apnea or chronic obstructive pulmonary disease. After 6 months, balloon removal was carried out, and patients were discharged with drug therapy and 1,000 kcal diet. More than 100 patients underwent a second consecutive balloon positioning. One month from the removal of the first BIB, patients were given a second BIB. Patients were followed up weekly. Mortality, complications and their treatment, postplacement symptoms, comorbidities, BMI, percentage of excess BMI loss (%EBL), and percentage of excess weight loss (%EWL) were considered. Data are expressed as mean ± standard deviation.
Results
From June 1, 2005, to May 31, 2007, 714 patients underwent BIB® placement (143 males/571 females; mean age, 38.4 ± 16.1; mean BMI, 37.6 ± 5.7 kg/m2; mean EW, 56.3 ± 27.1 kg). After 6 months, mean BMI was 31.1 ± 7.2, mean %EWL was 41.6 ± 21.8, mean BMI loss was 6.5 ± 12.7, and mean %EBL was 44.5 ± 22.6. Of 714 patients, 112 underwent a second BIB placement. At the time of the second balloon placement, mean BMI was 32.9 ± 6.7 kg/m2; range was 31–51. After the second balloon removal, mean BMI was 30.3 ± 7.2.
Conclusions
BIB® treatment is a safe and effective procedure for weight reduction, without mortality and with very low morbidity rates even in nonhospitalized patients. A second balloon can also be positioned without difficulties, achieving good results after 12 months of treatment.
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References
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.
Loffredo A, Cappuccio M, De Luca M, et al. Three years experience with the new intgragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001;11:330–3.
Genco A, Balducci S, Bacci V, et al. Intragastric balloon or diet alone? A retrospective evaluation. Obes Surg. 2008;18(8):989–92.
NIH Conference. Gastrointestinal surgery for severe obesity. Consensus development conference panel. Ann Intern Med. 1991;115:956–61.
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 ballon: 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.
Mathus-Vliegen EMH, Tytgat GNJ. Intragastric balloons for morbid obesity: results, patient tolerance and balloon life span. Br J Surg. 1990;77(1):77–9.
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(5):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.
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. Bioenterics Intragastric Balloon (BIB): a double blind, randomised, controlled, cross-over study. Int J Obes. 2006;30:129–3.
Genco A, Bruni T, Doldi SB, et al. BioEnterics Intragastric balloon: the Italian experience with 2, 515 patients. Obes Surg. 2005;15:1161–4.
Totté E, Hendrickx L, Pauwels M, et al. Weight reduction by means of intragatric device: experience with the bioenterics intragastric balloon. Obes Surg. 2001;11:519–23.
Hodson RM, Zacharoulis D, Goutzamani E, et al. Management of obesity with the new intragastric balloon. Obes Surg. 2001;11:327–9.
Roman S, Napoleon B, Mion F, et al. Intragastric balloon for ‘non morbid’ obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2004;14:539–44.
Sallet JA, Marchesini JB, Paiva DS, et al. Brazilian multicenter study on the intragastric balloon. Obes Surg. 2004;14:991–8.
Calle EE, Thun MJ, Petrelli JM, et al. Body mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999;341:1097–115.
Adams KF, Schatzkin A, Harais TB, et al. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006;355:763–78.
Deitel M. How much weight loss is sufficient to overcome major co-morbidities? Obes Surg. 2001;11:659.
Pasulka PS, Bistrian BR, Benotti PN, et al. The risks of surgery in obese patients. Ann Intern Med. 1986;104:540–6.
Pinkey JH, Sjostrom CD, Gale EA. Should surgeons treat diabetes in severely obese people? Lancet. 2001;1:357–9.
Melissas J, Mouzas J, Filis D, et al. The Intragastric Balloon—smoothing the path to bariatric surgery. Obes Surg. 2006;16:897–902.
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We thank Dr. Michele Lorenzo for his precious help.
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Lopez-Nava, G., Rubio, M.A., Prados, S. et al. BioEnterics® Intragastric Balloon (BIB®). Single Ambulatory Center Spanish Experience with 714 Consecutive Patients Treated with One or Two Consecutive Balloons. OBES SURG 21, 5–9 (2011). https://doi.org/10.1007/s11695-010-0093-3
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DOI: https://doi.org/10.1007/s11695-010-0093-3