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Efficacy, Safety, and Tolerance of Two Types of Intragastric Balloons Placed in Obese Subjects: A Double-Blind Comparative Study

Abstract

The intragastric balloon is a temporary treatment for obese patients. Fluid-filled devices have shown efficacy and safety, and are widely used. Recently, although there are no comparative studies between them, an air-filled balloon, Heliosphere® bag, has been proposed. Prospective, double-blind study in 33 patients with morbid and type 2 obesity: 23 female, 43.9 ± 10 years, 120.3 ± 17 kg, and body mass index (BMI) of 44.2 ± 5 kg/m2, placing 18 gastric balloons filled with 960 cm3 of air (Heliosphere® bag) or 15 balloons filled with 700 ml of saline (Bioenterics-BIB®). Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later. Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitamin supplements, and oral proton pump inhibitors, and were followed monthly. Complications, symptoms, weight, and quality of life evaluated by the Gastrointestinal Quality of Life Index (GIQLI) scale were recorded. At 6 months, mean weight loss (12.8 ± 8 vs 14.1 ± 8 kg), BMI loss (4.6 ± 3 vs 5.5 ± 3 kg/m2) and percent excess weight loss (27 ± 16 vs.30.2 ± 17) showed no significant differences between both groups. At removal, two Heliosphere® bags were not found in the stomach, and four patients required extraction of the balloon by rigid esophagoscopy or surgery (p = 0.02). Tolerance was good in both groups, but early removal occurred in three BIB® (20%) due to vomits and dehydration. The GIQLI total scores remained unchanged. Both balloons achieve a significant weight loss with good tolerance in obese patients. Nevertheless, Heliosphere® bag has severe technical problems that need to be solved before recommending it.

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Acknowledgments

This study was supported by the FISS grant PI07/90652 from the Science and Technology Ministry of Spain

Author information Authors and Affiliations

  1. Department of Gastroenterology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain

    Maria Luisa De Castro, Juan R. Pineda & Ignacio R. Prada

  2. Department of Endocrinology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain

    María José Morales, Eduardo Pena, José M. Sierra & María José Arbones

  3. Department of Epidemiology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain

    Víctor Del Campo

Authors
  1. Maria Luisa De Castro
  2. María José Morales
  3. Víctor Del Campo
  4. Juan R. Pineda
  5. Eduardo Pena
  6. José M. Sierra
  7. María José Arbones
  8. Ignacio R. Prada
Corresponding author

Correspondence to Maria Luisa De Castro.

About this article Cite this article

De Castro, M.L., Morales, M.J., 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 20, 1642–1646 (2010). https://doi.org/10.1007/s11695-010-0128-9

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