Current evidence on the safety and efficacy of electrical stimulation of the lower oesophageal sphincter for treating gastro‑oesophageal reflux disease (GORD) is limited in quantity and quality. Therefore, this procedure should only be used in the context of research.
NICE encourages clinicians to enter patients into controlled clinical trials. These could include crossover and cohort studies, which would allow inclusion of patients for whom other surgical options are unsuitable. These should provide a clear description of patient selection, and details of adjunctive medical and surgical treatments. Outcomes should include GORD symptoms, quality of life and objective measurements of gastric reflux. Efficacy, device durability, the need for surgical treatment for GORD in the longer term (at least 2Â years) and all complications should be reported. NICE may update the guidance on publication of further evidence.