ABSTRACT
BACKGROUND: The purpose of this study was to compare the effects of intensive nutritional care (INC) and laparoscopic adjustable gastric banding (LAGB) on nocturnal non-invasive ventilation (NIV) requirement in obese patients using short-, medium-, and long-term follow-up data. METHODS: This prospective randomized controlled trial included obese patients with obstructive sleep apnea (OSA) treated by NIV. Patients were randomized to the INC and LAGB groups. The primary endpoint was the theoretical rate of weaning from NIV at years 1 and 3. Data were also collected from patients 10 years after randomization. RESULTS: Sixty-three patients were randomized. The rate of weaning from NIV did not differ significantly between the LAGB and INC groups at year 1 (35 vs. 13%) or year 3 (14 vs. 21%). Percentages of excess weight loss were greater in the LAGB group than in the INC group at years 1 (33 vs. 15%, p = 0.002) and 3 (27 vs. 8%, p = 0.014). Decreases in the apnea-hypopnea index were observed in the LAGB group from baseline to year 1 (-44%, p = 0.001) and from baseline to year 3 (-26%, p = 0.044). After 10 years, the weaning rate was low and similar between groups. CONCLUSION: LAGB was not superior to INC for weaning from NIV at 1 and 3 years in obese patients with OSA.