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.
RCT Entities:
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.
Authors: A Genco; M Cipriano; V Bacci; M Cuzzolaro; A Materia; L Raparelli; C Docimo; M Lorenzo; N Basso Journal: Int J Obes (Lond) Date: 2006-01 Impact factor: 5.095
Authors: A Genco; T Bruni; S B Doldi; P Forestieri; M Marino; L Busetto; C Giardiello; L Angrisani; L Pecchioli; P Stornelli; F Puglisi; M Alkilani; A Nigri; N Di Lorenzo; F Furbetta; A Cascardo; M Cipriano; M Lorenzo; N Basso Journal: Obes Surg Date: 2005-09 Impact factor: 4.129
Authors: S B Benjamin; K A Maher; E L Cattau; M J Collen; D E Fleischer; J H Lewis; C A Ciarleglio; J M Earll; S Schaffer; K Mirkin Journal: Gastroenterology Date: 1988-09 Impact factor: 22.682
Authors: R B Hogan; J H Johnston; B W Long; J Q Sones; L A Hinton; J Bunge; S A Corrigan Journal: Gastrointest Endosc Date: 1989 Sep-Oct Impact factor: 9.427
Authors: B Coffin; V Maunoury; F Pattou; X Hébuterne; S Schneider; M Coupaye; S Ledoux; F Iglicki; F Mion; M Robert; E Disse; J Escourrou; G Tuyeras; Y Le Roux; C Arvieux; P Pouderoux; N Huten; T Alfaiate; D Hajage; S Msika Journal: Obes Surg Date: 2017-04 Impact factor: 4.129