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Search / Trial NCT05326113

The Effect of Physiotherapy on Post POEM Reflux

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Apr 8, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Per Oral Endoscopic Myotomy Reflux Physiotherapy Proton Pump Inhibitors Diapraghm Achalasia Lower Esophageal Sphincter

ClinConnect Summary

This clinical trial is studying the effects of physiotherapy on patients who have experienced reflux symptoms after a specific surgery for esophageal achalasia called per-oral endoscopic myotomy (POEM). After undergoing this surgery, many patients develop reflux, a condition where stomach acid flows back into the esophagus, which can be uncomfortable and may require long-term medication called proton pump inhibitors (PPIs) to manage the symptoms. The researchers believe that physiotherapy, which focuses on strengthening the diaphragm and lower chest area, might help reduce these reflux symptoms and lessen the need for medication.

To participate in the study, individuals must have been treated for esophageal achalasia with POEM and have reflux or esophagitis symptoms three months after the surgery. They also need to have a positive result on a specific test that measures acid levels in the esophagus. This trial is currently looking for participants aged between 6 and 74 years. Those who join can expect to receive specialized physiotherapy techniques designed to improve their symptoms, and the researchers hope to create helpful guidelines for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. esophageal achalasia (or other primary motility disease) treated by per oral endoscopic myotomy (POEM)
  • 2. symptomatic post-POEM reflux and/or esophagitis LA A/B/C (grade by The Los Angeles Classification) present 3 months after POEM surgery
  • 3. positive finding on esophageal 24hours pH Test 3 months after POEM surgery
  • 4. signed informed consent
  • Exclusion Criteria:
  • 1. reflux symptoms previously to the POEM surgery (except regurgitation)
  • 2. repeated POEM surgery
  • 3. Esophagitis of LA grade D
  • 4. asymptomatic pathologic reflux without signs of esophagitis 3 months post POEM surgery (patient is not indicated to use proton pump inhibitor "PPI" drugs)
  • 5. previous gastric surgery
  • 6. patients undergoing cancer treatment
  • 7. pregnancy
  • 8. known allergy or intolerance of proton pump inhibitor drugs
  • 9. other circumstances preventing participation in the study
  • 10. Inability to obtain informed consent

About Institute For Clinical And Experimental Medicine

The Institute for Clinical and Experimental Medicine (IKEM) is a leading research institution dedicated to advancing healthcare through innovative clinical and experimental studies. With a strong emphasis on translational research, IKEM aims to bridge the gap between laboratory discoveries and clinical applications, fostering collaboration among scientists, healthcare professionals, and industry partners. Its state-of-the-art facilities and multidisciplinary approach enable robust investigations into a wide range of medical conditions, ultimately striving to improve patient outcomes and contribute to the global body of medical knowledge.

Locations

Prague 4, Prague, Czechia

Patients applied

0 patients applied

Trial Officials

Kateřina Mádle

Principal Investigator

Charles University 2nd faculty of medicine, Prague, Czech Republic

Jan Martínek

Principal Investigator

Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Zuzana Vacková

Principal Investigator

Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Milan Martínek

Principal Investigator

Charles University Faculty of Physical Education and Sport

Lucie Zdrhová

Principal Investigator

Department of Internal Medicine, Pilsen, Czech Republic

Alena Kobesová

Principal Investigator

Charles University 2nd faculty of medicine, Prague, Czech Republic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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