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.