Exploring the feasibility and safety of laparoscopic anti-reflux surgery with the new RefluxStop™ device: a retrospective cohort study of 40 patients

Abstract

AIMS OF THE STUDY: Anti-reflux surgery aims to restore the anti-reflux barrier and reduce the retrograde flow of stomach contents. However, traditional surgical techniques generally involve some degree of encircling of the oesophagus, which can result in adverse effects such as dysphagia and the inability to belch or vomit. Based on the first published results, a novel surgical technique – with the RefluxStop™ device – appears promising for treating gastroesophageal reflux disease (GERD) with minimal postoperative dysphagia. This study describes the initial clinical experience with this procedure in a cohort of patients with chronic gastroesophageal reflux disease to evaluate its feasibility and safety in clinical practice. METHODS: This retrospective cohort study examined the first 40 patients who underwent laparoscopic anti-reflux surgery with the RefluxStop™ device at a private hospital in Switzerland. The procedure involves implanting a nonactive device on the outside of the gastric fundus to stabilise a narrow oesophagogastric plication. Feasibility was assessed based on the proportion of patients in whom the device could be successfully implanted, with a discussion of the operative details. Intraoperative and postoperative complications, adverse effects, and changes in gastroesophageal reflux disease-related quality of life (GERD-HRQL questionnaire) are also reported. RESULTS: Between May 2020 and April 2022, 40 patients underwent elective surgery for laparoscopic hiatal hernia repair and RefluxStop™ device implantation. All patients had typical symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation; 20 (50%) had preoperative dysphagia. Laparoscopic surgery was feasible in all patients except one who required laparotomy due to adhesions and associated bleeding when accessing the abdomen. The median operating time was 57.5 minutes (interquartile range = 51.75–64.25 minutes) with no device-related intraoperative or postoperative complications. All patients were imaged one day and three months postoperative, confirming the correct placement of the device. Reflux symptoms (heartburn and acid regurgitation) were significantly improved in all patients at three months (p <0.0001). CONCLUSION: These preliminary results support the feasibility and safety of introducing this novel laparoscopic anti-reflux surgical treatment option in clinical practice.