Safety and clinical outcomes of RefluxStop procedure: systematic review and meta-analysis

Gastroesophageal reflux disease (GERD) is a common disorder with multifactorial pathogenesis. Owing to the chronic nature of the disease and the long-term side effects of medical therapy, surgical interventions have gained popularity. RefluxStop is a newly introduced minimally invasive technique for treating GERD. This meta-analysis aimed to build high-level evidence on the effectiveness and safety of the RefluxStop procedure.

This systematic review and meta-analysis analysed the results of primary studies reporting clinical outcomes of RefluxStop.

Of 188 screened articles, 5 studies involving 296 patients were included. Most patients (99.7%) underwent laparoscopic RefluxStop procedures. Preoperative dysphagia was noted in 23.6% of patients. Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores were reported in 4 studies using different scoring versions. In 169 patients, the pooled preoperative mean GERD-HRQL score was 27.96, which improved to 3.89 postoperatively. The overall complication rate was 15.2%, with surgical emphysema being the most common (40.0%). Device-related complications occurred in 4 patients, including migrations, slippage, and gastric penetration. Of note, 2 cases had incorrect device placement. Patient satisfaction was high (93.9% in 3 studies), and 2 mortalities occurred due to unrelated medical causes.

RefluxStop shows promising results with significant improvement in GERD-HRQL scores postoperatively. The overall complication rate was 15.2%. Excluding cases with surgical emphysema, which were all self-limiting, the complication rate was 9.1%, and the major complication rate (Clavien-Dindo grades 3 and 4) was 3.0%. Further studies are needed to assess the long-term safety and effectiveness of RefluxStop.