Safety and effectiveness of gastric balloons associated with hypocaloric diet for the treatment of obesity.
BACKGROUND
intragastric balloons provide early satiety and thereby induce short-term weight loss. The aim of this study was to evaluate safety and short and medium-term effectiveness of gastric balloons associated to hypocaloric diet in obesity.


METHODS
from May 2004 to June 2011 91 obese patients, body mass index (BMI) 45.2 +/- 7.2 kg/m2 were prospectively followed after endoscopic implantation of a gastric balloon associated to restricted diet. Successful therapy was defined as percent loss of total weight (%LTW) > or = 5 % at six months after balloon placement and 6 and 12 months after their withdrawal. All analyses followed intention-to treat principles considering significant p-values < 0.05.


RESULTS
we placed 73 fluid-filled balloons (80.2 %) and 18 air-filled ones (19.8 %). Compared to baseline values, at 6-month 73.7 % subjects succeeded, showing significant reductions in weight (13.3 +/- 8.8 kg), BMI (5 +/- 3.4 kg/m2) (p < 0.0001), with % LTW 11 +/- 7 %. Six and twelve months after retrieval 45.1 % and 28.6 % patients reached % LTW > or = 5 %. Short-term and medium-term effectiveness was negatively associated to obesity in first-grade relatives (p = 0.003 and p = 0.04). Higher weight loss 6 months after balloon placement independently predicted medium-term effectiveness (p = 0.0001). Mortality was absent but there were two spontaneous deflations of air-filled balloons and severe withdrawal difficulties in 8 patients, leading to surgery in one case. Retrieval complications associated to air-filled balloons (p = 0.0005).


CONCLUSIONS
in obesity, effectiveness of gastric balloons associated to hypocaloric diet decreases over time.Complications occurred mainly in the retrieval endoscopic procedure and related to air-filled balloons.
Maria Luisa
ML
de Castro
Maria Jose
MJ
Morales
Miguel A
MA
Martínez-Olmos
Juan R
JR
Pineda
Lucia
L
Cid
Pamela
P
Estévez
Victor
V
del-Campo
J Ignacio
JI
Rodríguez-Prada
D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004038:Diet, Reducing / Q000009:adverse effects; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy / Q000628:therapy*; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome; D055815:Young Adult