Safety and effectiveness of gastric balloons associated with hypocaloric diet for the treatment of obesity

Abstract

Introduction: 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. Material and 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) ≥ 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 ≥ 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.

Keywords

• Obesidad
• Obesidad mórbida
• Balón intragástrico
• Endoscopia