Clinical outcomes of RefluxStop for gastroesophageal reflux disease

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Created On: 04/06/2026

Gastroesophageal reflux disease (GERD) is a chronic, multifactorial disorder that can be challenging to tackle with long-term medical therapy alone.

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Key take away

RefluxStop markedly reduces GERD-HRQL scores while maintaining a 95.5% patient satisfaction rate.

Background

Gastroesophageal reflux disease (GERD) is a chronic, multifactorial disorder that can be challenging to tackle with long-term medical therapy alone. RefluxStop is a novel minimally invasive surgical approach developed to control reflux without constricting the oesophagus. This systematic review and meta-analysis explored the clinical efficacy and safety of RefluxStop (minimally invasive laparoscopic surgery) in GERD.

Method

All primary studies that reported clinical outcomes after RefluxStop implantation were included. Of 188 screened articles, 6 studies fulfilled the eligibility criteria encompassing 336 patients. Among the 336 patients, 99.4% underwent laparoscopic RefluxStop implantation, with only two procedures converted to open surgery.

Result

Preoperative dysphagia was present in 27.9% of patients. GERD-health related quality of life (GERD-HRQL) outcomes were reported in 5 studies; pooled data from 169 patients exhibited a marked reduction in mean GERD-HRQL scores from 27.96 before surgery to 3.89 after the procedure. The cumulative complication rate was found to be 14.58%, with surgical emphysema accounting for 36.7% of reported complications. Device-linked adverse events occurred in 4 volunteers and included migration, gastric penetration, and slippage.

Notably, 2 procedures were considered technical failures because of incorrect device placement. Overall, 12 patients required additional surgical or endoscopic intervention, and 1 patient experienced an intraoperative oesophageal perforation. Despite these events, patient satisfaction remained high at 95.5% across 5 studies. Two deaths were reported during follow-up, although both were attributed to causes unrelated to the procedure.

Conclusion

RefluxStop was associated with remarkable improvement in GERD symptoms and excellent patient satisfaction, producing lower postoperative GERD-HRQL scores than those reported for magnetic sphincter augmentation and fundoplication. However, the procedure carried a notable complication rate and device-related risks, highlighting the need for larger studies with longer follow-up to confirm its long-term safety and potency.