RefluxStopTM, a Novel Device to Address Gastroesophageal Reflux Disease: Short-term Results

Abstract Objective To report safety, feasibility, and patient’s functional short-term outcome of novel RefluxStop anti reflux operation. Methods All patients (n = 20) who received laparoscopic implantation of the RefluxStop device from September 2018 to November 2020 in a university hospital were included for retrospective analysis. Incidence of adverse device-effects and procedure-related adverse events are reported as safety endpoints. Feasibility was assessed reporting operation duration, rate of conversion to open surgery and technically correct position of the device by control radiography during patient’s follow up. Subjective (Gastroesophageal Reflux Disease - Health Related Quality of Life (GERD-HRQL) - questionnaires; after 6 weeks and every six-month thereof) and objective data (24h-pH-manometry, barium swallows and upper endoscopies) are reported as functional outcome parameters. Comparison between values at baseline versus post-procedure follow-up are performed using the paired samples T-test, if appropriate. Results Median follow up was 4 (1 – 22) month. Three out of 20 patients had previous upper gastrointestinal surgery (EndoStim implantation). No serious adverse device related events occurred. One patient with dysphagia required balloon dilatation at the oesophageal gastric junction 4 weeks postoperatively. Median duration of surgery was 85 (59-188) minutes. There was no conversion to open surgery. There was significant reduction in the mean of total GERD-HRQL score at baseline compared to 6-weeks after surgery with 23.9 and 4.3 (p < 0.001) as well as at baseline and 6 month after surgery with 28.4 and 6.8 (p = 0.021), respectively. At 6 weeks follow up, all of the subjects had over 50% improvement of the GERD-HRQL score compared to baseline. One patient with acceptable device positioning developed symptom recurrence and received conversion to laparoscopic Toupet fundoplication after 10 months. Conclusion RefluxStop procedure seems to be a safe operation with promising short-term results. For high-level recommendation, further studies looking for long-term results and randomized comparisons to the standard anti reflux procedures like Nissen or Toupet fundoplication are required.