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.