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

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.

Laparoscopic Large Hiatal Hernia Repair With RefluxStop: Outcomes of Six Months Follow-up in Thirty Patients.

OBJECTIVE: The antireflux surgical technique with the RefluxStop device is one of the latest approaches to treating patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the safety and feasibility of laparoscopic hiatal hernia (HH) repair with the RefluxStop device in patients with GERD and concurrent large HH (≥4 cm). PATIENTS AND METHODS: A retrospective chart review was performed for the first 30 patients with a large HH who consented and underwent HH surgery with the RefluxStop device. The operative technique and outcomes were evaluated to assess safety and feasibility, HH recurrence, dysphagia, and patient satisfaction. RESULTS: Between May 2020 and April 2022, 30 patients underwent laparoscopic HH repair with the RefluxStop device. All patients had typical symptoms of GERD, such as heartburn and regurgitation, and 15 patients (50%) had preoperative dysphagia. Median HH size was 5 cm (interquartile range, 4 to 5). Median operating time was 56 minutes (interquartile range, 52 to 63), with no intra and postoperative complications related to the device. One patient required laparotomy due to adhesions and associated bleeding when accessing the abdomen. All patients had postoperative imaging (video fluoroscopy) on postoperative day 1 and at 3 months, confirming the correct location of the RefluxStop device. One patient (3.3%) needed postoperative balloon dilatation due to severe dysphagia. Reflux symptoms (heartburn and acid regurgitation) resolved significantly in all patients ( P < 0.001) at 6 months. One episode of recurrence of HH (3.3%) occurred during the follow-up period of 6 months. CONCLUSION: This study demonstrates the short-term safety and feasibility of laparoscopic HH repair with the RefluxStop device in patients with large HH, with a low rate of postoperative dysphagia and subsequent improvement or resolution of reflux symptoms in all patients.

Short-term results of laparoscopic anti-reflux surgery with the RefluxStop device in patients with gastro-esophageal reflux disease and ineffective esophageal motility.

PURPOSE: In gastro-esophageal reflux disease (GERD) requiring surgical treatment, concomitant ineffective esophageal motility (IEM) is a decisive factor in surgical planning, due to concern regarding dysphagia. Anti-reflux surgery with the RefluxStop device is a promising technique. We assessed initial feasibility and clinical outcomes of RefluxStop surgery in patients with GERD and IEM. METHODS: Retrospective analysis of patients with GERD, hiatal hernia (HH), and IEM, who underwent surgery with RefluxStop at our institution and achieved 12-month follow-up. Technique feasibility was assessed, in addition to symptom resolution (GERD-HRQL questionnaire), adverse events, HH recurrence, dysphagia, and patient satisfaction. Placement of the device was confirmed by video fluoroscopy on postoperative day 1, and at 3 and 12 months. RESULTS: Between June 2020 and November 2022, 20 patients with IEM underwent surgery with RefluxStop and completed 12-month follow-up. All patients reported typical symptoms of GERD, and 12 had preoperative dysphagia. The median HH length was 4.5 cm (IQR, 3.75-5). The median operating time was 59.5 min (IQR, 50.25-64) with no implant-related intra- or postoperative complications. No HH recurrence was observed. One patient reported persistent left-sided thoracic pain at 11 months post-surgery, which required diagnostic laparoscopy and adhesiolysis. Three patients reported severe postoperative dysphagia: balloon dilatation was performed towards resolution. The mean GERD-HRQL scores improved (from 40.7 at baseline to 4.8 at 3 months and 5.7 at 12 months (p <0.001)). CONCLUSION: RefluxStop surgery was feasible and offered effective treatment for this group of patients with GERD and IEM. All patients had complete resolution or significant improvement of GERD symptoms, and 90% of them were satisfied with their quality of life 1 year after surgery.