Laparoscopic anti-reflux surgery with the RefluxStop implant for severe sufferers with complex disease: A retrospective study of the first 100 patients with 12-month follow-up at our early adopter institution
Abstract
BACKGROUND
The RefluxStop procedure, shown to effectively eliminate gastroesophageal reflux disease (GERD) symptoms in clinical trial, has been offered at our clinic since 2020. Promising short-term outcomes in initial cohorts have been published; we now present outcomes for 100 patients with follow-up of at least 1 year.
METHODS
A retrospective cohort study was performed with the first 100 patients to reach 12-month postoperative follow-up. The primary endpoint was symptom resolution, quantified using the GERD Health-Related Quality of Life (GERD-HRQL) score; secondary effectiveness endpoints included patient satisfaction and proton pump inhibitor (PPI) use. Safety data were reported as surgical complications up to 90 days and device- or surgery-related complications during the 12-month follow-up.
RESULTS
At baseline, 53% of the patients had hiatal hernia of ≥4cm, 66% had ineffective esophageal motility, and 46% reported preoperative dysphagia. Median (IQR) GERD-HRQL score (0-75 points) decreased by 97.6% from 42.5 (29-50) preoperatively to 1.0 (0-5) at 12 months (p7cm at baseline.
CONCLUSION
In this cohort of 100 severe sufferers, the RefluxStop procedure resulted in excellent 12-month outcomes with median 97.6% improvement in total GERD-HRQL score, resolving GERD symptoms to a high level of satisfaction, even in clinically complex patient groups.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 100 participants or records.
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