Tolerance and efficacy of an air-filled balloon in non-morbidly obese patients: results of a prospective multicenter study.
BACKGROUND
Intragastric balloons have been proposed to induce body weight loss in obese subjects. Most studies were performed using liquid-filled balloons. Air-filled balloons may increase digestive tolerance. Our goal was to study the tolerance and efficacy of a new air-filled intragastric balloon in nonmorbidly obese patients.


METHODS
32 patients were included, with a mean BMI of 35.0 (range 30.1-40.0). The balloon was inserted under general anaesthesia, inflated with 800 ml of air, and removed 4 months later. Tolerance and body weight were monitored until 12 months after removal. Ghrelin levels were measured before balloon insertion, 1 and 4 weeks after, and before removal.


RESULTS
Weight loss was significant at 1, 2 and 4 months after balloon insertion (6, 7 and 10 kg, respectively, P<0.001). Early removal of the balloon occurred in 3 cases. 28 patients were contacted 12 months after balloon removal: 2 had undergone gastric banding; among the 26 remaining, the mean weight loss was 7 kg. 9 patients (30%) remained with a weight loss >10%, and satisfaction with the method was 87% for these 9 patients, and 22% for the other patients who had weight loss <10% (P<0.04). Fasting plasma ghrelin levels increased at week 1 and 4 after balloon insertion, and decreased at week 16 (P<0.001). CONCLUSIONS. The air-filled intragastric balloon was safe. Its effect on weight loss appeared equivalent to other balloons. 12 months after balloon removal, 30% of the patients maintained a weight loss >10%.
Mion
François
F
Hospices Civils de Lyon, Fédération des Spécialités Digestives, Hôpital E. Herriot, Lyon, France. francois.mion@chu-lyon.fr
Gincul
Rodica
R
Roman
Sabine
S
Beorchia
Sylvain
S
Hedelius
Frank
F
Claudel
Nicolas
N
Bory
Roger-Michel
RM
Malvoisin
Etienne
E
Trepo
Frédérique
F
Napoleon
Bertrand
B
D000293:Adolescent; D000328:Adult; D000388:Air; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D015905:Gastric Balloon; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss