Sebastian F. Schoppmann, Joerg Zehetner, Moustafa Elshafei, Thorsten Lehmann, Ahmed Ahmed, Naim Fakih-Gomez, Joy Feka, Fergus Noble, Nicholas Boyle, María Eugenia Barrios Carvajal, Alberto Hernández Matías, J. Daniel Sánchez López, Marta Cuadrado Ayuso, Beatriz Guil Ortíz, Carlos Miliani Molina, Carlos Moreno Sanz, G.P. Da Pozzo, Maurizio Pavanello, Adolfo Renzi, Davide Bona, Leonardo Vincenti, Luigi Bonavina, Yves Borbély, John C. Lipham
RefluxStop surgery aims to restore a functional anti-reflux barrier in gastroesophageal reflux disease (GERD) without encircling the esophagus, purportedly limiting dysphagia and gas-bloating. This report presents safety outcomes from 602 patients at 22 centers across six European countries and up to 6.75 years follow-up (mean [SD] 2 [1.25] years). Serious safety outcomes and reoperation occurred in 1.99% (12/602), all satisfactorily resolved. Thereof, two-thirds were reherniations (1.33%), which manifested from total disruption of crural repair, resolved by straightforward fundic repositioning and redo hiatal repair with RefluxStop unaffected in its pouch. Non-operative safety events included 4/602 (0.66%) cases of asymptomatic erosion (without action) in the early postoperative phase (4 weeks) as the learning curve of a new procedure. Dilatation for new-onset dysphagia was performed in one patient. This report presents an analysis focused on safety data from the largest independent RefluxStop study to date (n = 602). Despite inter-surgeon variability, the learning curve for a new procedure, and sizable proportions of large hernia and/or dysmotility patients, results show low rates of serious safety outcomes with reoperations occurring in <2%. The overall experience of the RefluxStop Evaluation Group demonstrated a consistent and favorable mid-to-long-term safety profile for RefluxStop in real-world surgical treatment of GERD.