Three-Year Outcomes of Reflux Esophagitis and Late Complications After FundoRing Versus Standard One-Anastomosis Gastric Bypass: a Randomized Controlled Trial.

BACKGROUND/

OBJECTIVES

The FundoRing gastric bypass method has suggested improved antireflux effects after one year of follow-up compared to standard one-anastomosis gastric bypass (OAGB). However, longer-term impact on adverse effects remains unclear. This study aimed to compare three-year outcomes of reflux esophagitis and other late postoperative complications between the FundoRing method and standard OAGB. This manuscript presents a pre-specified secondary analysis of these endpoints from a single-center RCT. This article is structured as an original research report with detailed technical description and exploratory secondary outcome analysis.

METHODS

This was a single-center, prospective, interventional, open-label randomized controlled trial (FundoRing Trial) with a 3-year follow-up period. The registered primary endpoint was weight loss; the present analysis focuses on pre-specified secondary endpoints: assessment of reflux esophagitis and other late postoperative complications.

RESULTS

Overall, 1000 patients (n = 500 per group) were randomized and included in the intention-to-treat analysis. Three-year follow-up rates were 83% in the f-OAGB group and 87% in the s-OAGB group. There were no deaths in either group. The DeMeester index 3 years after surgery was significantly lower in the f-OAGB group (3.97 ± 1.8 vs. 7.2 ± 7.4; difference 3.23; 95% CI: 1.82-4.64; p < 0.001). At 3-year follow-up, f-OAGB was associated with significantly lower rates of dumping syndrome symptoms, marginal ulcer incidence, and other late complications compared to s-OAGB.

CONCLUSIONS

This trial compared two composite techniques that differ in both fundoplication and gastric pouch length (10 cm in f-OAGB vs. 15-18 cm in s-OAGB). Within this context, three-year follow-up of the FundoRing method compared to standard OAGB suggests improved results on 24-hour pH impedance monitoring and a reduction in several late complications, including bile reflux esophagitis, marginal ulcers, and dumping syndrome. However, due to the structural confounding between fundoplication and pouch length, causal attribution of these benefits to the fundoplication alone is not possible. Clinically, f-OAGB may be considered for patients at high risk for bile reflux, but further validation is required. The findings should be interpreted as exploratory. Further multicenter studies with standardized pouch volumes are needed to disentangle the individual contributions of each technique component and to establish the generalizability of these results.