Refluxstop Versus Fundoplication in the Treatment of Refractory Gastro-Oesophageal Reflux Disease: A Systematic Review & Meta-Analysis

Background Gastro-oesophageal reflux disease (GORD) affects 13.98% globally, significantly impacting quality of life. While PPIs are first-line treatment, up to 50% of patients have refractory GORD. Fundoplication, the gold-standard surgical option has high rates of post-operative symptoms. RefluxStop, a non-active silicone implant, offers an anatomy-preserving alternative with fewer complications. This review addresses the lack of comparative data on postoperative outcomes, including PPI use, quality of life, patient satisfaction, and symptom resolution. AIMS Methods A systematic search was conducted in PubMed and Cochrane Central, using Boolean operators to identify studies on RefluxStop, fundoplication, and GORD outcomes. Studies from 2017 onwards in English were included. Eligible study types were RCTs, cohort, case–control, and cross-sectional studies. Data was extracted into SPSS 29.0, with statistical analyses including t-tests, Pearson correlations, and effect size calculations. This review followed PRISMA guidelines. Results Nine Fundoplication studies (follow-ups up to 144 months) and six RefluxStop studies (follow-ups up to 48 months) were included. RefluxStop had significantly greater QoL improvements (87.98% vs. 45.94%, p < 0.001, d = 2.32) and patient satisfaction (90.77% vs. 81.71%, p = 0.034, d = 1.35). Post-operative PPI use was lower in RefluxStop (4.26% vs. 27.38%, p < 0.001, d = 2.80). Post-operative indigestion (p = 0.042, d = 1.21) and dysphagia (p = 0.017, d = 0.99) were significantly higher in fundoplication. No differences were found in regurgitation (p = 0.106) or bloating (p = 0.465). Male patients had lower post-op PPI use (r = 0.468, p = 0.037). Post-op PPI use negatively correlated with satisfaction (r = −0.840, p = 0.009). Follow-up duration had no significant impact. Conclusion This systematic review is the first to compare RefluxStop and fundoplication in refractory GORD management. RefluxStop demonstrated greater QoL improvements, higher patient satisfaction, and lower post-op PPI use than fundoplication, which had higher rates of dysphagia and heartburn. While both effectively controlled reflux, long-term RefluxStop data is lacking. Larger, multi-centre RCTs with extended follow-up are needed to confirm durability, assess safety, and refine patient selection. Standardised pH monitoring and cost-effectiveness analyses should guide future surgical recommendations.