Experience With an Innovative Surgical Treatment Option for Gastroesophageal Reflux Disease: Results of 28 Patients...

Standard-of-care gastroesophageal reflux disease (GERD) procedures are associated with adverse events (AEs) (i.e., dysphagia, gas-bloating). RefluxStop has been developed to circumvent these outcomes. This study presents the results of 28 patients managed with RefluxStop in Germany. Between July 2021 and November 2023, 28 patients with GERD underwent RefluxStop surgery, a novel laparoscopic antireflux procedure. Retrospective chart analysis with patient-informed consent was conducted to determine clinical outcomes, such as GERD Health-Related Quality of Life (GERD-HRQL) score, proton pump inhibitors (PPI) use, symptomatology, patient satisfaction, and perioperative AEs. Baseline characteristics (n = 28): age 47 ± 13.1 years; 67.9% female; body mass index (BMI) 27.3 ± 4.1 kg/m²; 93% PPI use for 5.6 ± 2.7 years; and hiatal hernia in 100% of cases of mean (standard deviation [SD]) size 3.4 (0.8) cm, whereof 35.7% were large hiatal hernia (4-6 cm). At a mean (SD) follow-up of 14.1 (4.7) months, patients experienced 88.6% improvement in median (IQR) total GERD-HRQL score from a baseline of 35 (7.7) to 4 (4.2) at follow-up (P < .05). Preoperative dysphagia (35.7%) resolved completely in all patients (P < .001). The mean (SD) GERD-HRQL heartburn subdomain decreased by 90.6% from a baseline of 18.1 (6.1) to 1.7 (1.2) at follow-up and all patients (100%) had scores <5. Similarly, the mean (SD) regurgitation subdomain decreased from a baseline of 13.2 (4.7) to 2 (1.6) at follow-up and all patients (100%) had scores <5. Patient satisfaction was achieved in 96.4% of patients with no PPI use required in 93% of patients (P < .001); only one patient required PPIs for persistent GERD symptoms. No cases of reoperation or esophageal dilatation were performed. Minor intraoperative AEs occurred in seven patients (i.e., neck emphysema). RefluxStop provides excellent safety and effectiveness outcomes for GERD treatment. Dysphagia completely resolved (0%) with 88.6% improvement in median GERD-HRQL score and satisfaction achieved in 96.4% of patients. These promising results reproduced the outcomes noted in the RefluxStop CE trial in real-world settings.