A Randomized Controlled Trial of Reflux Esophagitis and Other Late Postoperative Complications: 3-Year Follow-Up Results in the FundoRingOAGB Trial

Background/Objectives : The new FundoRing gastric bypass method demonstrates improved antireflux effects after one year of follow-up compared to standard one anastomosis gastric bypass (OAGB). However, the longer-term impact of this innovation on adverse effects remains unclear. The aim of this study was to compare three-year follow-up of reflux esophagitis and other late postoperative complications between the FundoRing method and standard one anastomosis gastric bypass. Methods : This was a single-center, prospective, interventional, open-label (no masking) RCT (FundoRing Trial) with a 3-year follow-up period. The endpoints were assessment of reflux esophagitis, and other late postoperative complications. Results: Overall, 1000 patients (n=500 FundoRing One-anastomosis gastric bypass [f-OAGB] vs. n=500 standard OAGB [s-OAGB]) with complete follow-up data were included in the study. No mortality occurred in either group. The DeMeester index 3- years after surgery was significantly lower in the f-OAGB group (3.97 ± 1.8 versus 7.2 ± 7.4; difference 3.23; 95% CI: 1.82–4.64; p<0.001). At 3-year follow-up FundoRingOAGB significantly decrease dumping syndrome symptoms, marginal ulcer and other late complications. Conclusions: A three-year follow-up of the FundoRing method compared to standard one anastomosis gastric bypass confirms improved results of surgery, including 24-hour pH impedance monometry, and a reduction of late complications.