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Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia
Sponsor: Institute for Clinical and Experimental Medicine
Summary
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.
Official title: A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-04-01
Completion Date
2027-06-01
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
Per Oral Endoscopic Myotomy (POEM)
All procedures will be performed by an experienced endoscopist, with a sufficient experience in "third space" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the procedure consists of 4 steps: (1) mucosal incision and tunnel entry, (2) submucosal tunneling, (3) myotomy, and (4) closure of the mucosal entry with endoscopic clips or other closure devices. Perioperative protocol might differ according the usual way of performing POEM in a given center.
Locations (2)
St. Anne's University Hospital Brno, Czech Republic
Brno, Czechia
University Hospital Trnava
Trnava, Slovakia