Learning Curve of the Laparoscopic RefluxStop Procedure for the Treatment of Gastroesophageal Reflux Disease.

Abstract

Background: The RefluxStop (RS) is an innovative surgical procedure for the treatment of gastroesophageal reflux disease (GERD). Prior research has demonstrated encouraging results in medium-term follow-ups, suggesting that this procedure is a worthwhile alternative to conventional laparoscopic antireflux surgery (LARS). Despite the standardization of the surgical technique, the procedure may be laborious and demanding even for an expert foregut surgeon. Aim: Evaluate the surgeon learning curve for the RS procedure. Methods: A single-center prospective study (December 2023-January 2025) was conducted. All the procedures were performed by one surgeon experienced in LARS. The cumulative summation (CUSUM) methodology was applied to visualize the learning curve. A broken-line regression model was employed to identify transitions between phases, thus defining competency (phase 1), proficiency (phase 2), and mastery (phase 3). Results: Fifty consecutive RS procedures were included. The mean age was 46.7 years (standard deviation [SD]: 11.4), and 68% patients were females. Heartburn (100%), regurgitation (88%), and dysphagia (28%) were common symptoms. Hiatal hernia axial length ranged from 2 to 5 cm. The mean preoperative GERD-HRQL was 39.1 (SD: 9.2). None of the patients underwent concomitant procedures, and the mean operative time was 70.6 minutes (SD: 17.3). The regression analysis found breakpoints at case 9.32 (95% CI: 8.5-9.9) and case 23.27 (95% CI: 22.9-23.8). Thus, the competency phase was achieved after 9 cases, followed by the proficiency phase, which was completed after an additional 14 cases (up to case 23). The surgeon achieved mastery of the RS procedure upon completing 23 cases. Conclusions: The CUSUM learning curve for the laparoscopic RS procedure demonstrates that a surgeon experienced in LARS requires 9 cases to overcome competency and 23 cases to master the technique.