Status:
RECRUITING
The Effect of Physiotherapy on Post POEM Reflux
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Conditions:
Reflux, Gastroesophageal
Achalasia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Per-oral endoscopic myotomy has been used as a treatment method of esophageal achalasia. Patients who undergo POEM as a treatment of achalasia are often presented with development of reflux as a side ...
Detailed Description
The goal per-oral endoscopic myotomy (POEM) is to release a non-relaxing, often spastic lower esophageal sphincter (LES). During POEM an incision of the esophageal muscle layer (m.propria) is performe...
Eligibility Criteria
Inclusion
- esophageal achalasia (or other primary motility disease) treated by per oral endoscopic myotomy (POEM)
- symptomatic post-POEM reflux and/or esophagitis LA A/B/C (grade by The Los Angeles Classification) present 3 months after POEM surgery
- positive finding on esophageal 24hours pH Test 3 months after POEM surgery
- signed informed consent
Exclusion
- reflux symptoms previously to the POEM surgery (except regurgitation)
- repeated POEM surgery
- Esophagitis of LA grade D
- asymptomatic pathologic reflux without signs of esophagitis 3 months post POEM surgery (patient is not indicated to use proton pump inhibitor "PPI" drugs)
- previous gastric surgery
- patients undergoing cancer treatment
- pregnancy
- known allergy or intolerance of proton pump inhibitor drugs
- other circumstances preventing participation in the study
- Inability to obtain informed consent
Key Trial Info
Start Date :
October 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 18 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05326113
Start Date
October 31 2021
End Date
January 18 2025
Last Update
March 7 2024
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine
Prague, Prague, Czechia, 14021