Sleeve Gastrectomy with Roux-en-y Transit Bipartition versus Sleeve Gastrectomy for the Treatment of Obesity and Reflux: A Multicenter Randomized Controlled Trial.

BACKGROUND: Laparoscopic Sleeve Gastrectomy (SG) is associated with a significant risk of de novo or worsening Gastroesophageal Reflux Disease (GERD). Sleeve Gastrectomy with Roux- en-y Transit Bipartition (SG-TB) has been proposed as an alternative procedure to mitigate reflux. This study aims to compare the efficacy and safety of SG versus SG-TB in controlling GERD in patients with obesity. METHODS: A multicenter, prospective, pilot randomized controlled trial (ID: researchregistry11842) was conducted in three high- volume bariatric centers. A total of 120 patients with obesity were randomized to either SG (n = 60) or SG-TB (n = 60). The methodological core was the assessment of GERD, based on 24- hour pH-impedance monitoring performed at baseline and at 12 months. RESULTS: At 12 months, the SG-TB group showed a significantly lower incidence of de novo GERD compared to the SG group (3.3% vs. 28.3%; p < 0.001). At 12 months, mean Acid Exposure Time (AET) was significantly lower after SG-TB than after SG (1.9% vs. 7.5%, p < 0.001) and remained numerically unchanged from the SG-TB baseline value of 1.9%. The SG-TB group also demonstrated a higher % of total weight loss and % Excess Weight Loss (%TWL: p < 0.001; %EWL: p = 0.002). CONCLUSIONS: In this multicenter pilot RCT, SG-TB was associated with a significantly lower incidence of de novo GERD compared to SG at 12 months in carefully selected patients without severe pre-existing GERD. These short-term findings are encouraging; however, definitive conclusions regarding the superiority of SG-TB cannot be drawn on the basis of 12- month data alone. Longer follow-up is required to assess the durability of reflux outcomes, late nutritional safety, and late GERD relapse.