Abstract
BACKGROUND: This study reports outcomes of the RefluxStop procedure treating gastroesophageal reflux disease (GERD) in clinical practice at a high-volume regional hospital in Germany. METHODS: A retrospective analysis was conducted on 79 patients with chronic GERD that underwent the RefluxStop procedure, comprising high mediastinal dissection, loose cruroplasty, esophagogastroplication between vagal trunks, and fundus invagination of the RefluxStop implant. The primary outcome was GERD Health-Related Quality-of-Life (GERD-HRQL) score and improvement from baseline. Secondary outcomes included proton pump inhibitor (PPI) use and intra- and postoperative complications, including dysphagia, esophageal dilatation, and reoperation. RESULTS: Baseline characteristics (n = 79) included large hiatal hernia >3 cm (32.4 %) and previous antireflux surgery (20.3 %). At mean (SD) follow-up of 11 (4.4) months ranging from 4 to 19 months, the median (IQR) and mean (SD) improvements in GERD-HRQL score were 100 % (90.2-100 %) and 92.4 % (13.9 %) from baseline, respectively. Significant reduction in PPI use was observed from a baseline of 94.9 % to 2.5 % at follow-up. All cases of preoperative dysphagia (7.6 %) completely resolved. New-onset, mild dysphagia occurred in one subject (1.3 %) at final follow-up. One subject (1.3 %) experienced asymptomatic device migration into the stomach, likely due to surgical technique with a much too tight invagination, with subsequent conversion to Toupet fundoplication. CONCLUSION: Analysis of this cohort that underwent RefluxStop surgery indicates excellent safety and effectiveness over this short-term follow-up. Significant improvements in quality of life and PPI use were observed in a population where half had either large hiatal hernia >3 cm or reoperation for previously failed antireflux surgery, a demographic with usually much higher complication rates.