Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia

Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.

NCT Number	NCT06872255
Lead Sponsor	Institute for Clinical and Experimental Medicine Collaborators: University Hospital Trnava, St. Anne's University Hospital Brno, Czech Republic
Conditions	Dysphagia, Dysphagia, Esophageal, Healthy
Enrollment	30 participants
Start Date	2025-04-01
Primary Completion	2027-06-01 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-12