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

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2027

Conditions
DysphagiaDysphagia, EsophagealHealthy
Interventions
PROCEDURE

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."

Trial Locations (2)

60200

St. Anne's University Hospital Brno, Czech Republic, Brno

91701

University Hospital Trnava, Trnava

All Listed Sponsors
collaborator

University Hospital Trnava

NETWORK

collaborator

St. Anne's University Hospital Brno, Czech Republic

OTHER

lead

Institute for Clinical and Experimental Medicine

OTHER_GOV