Physiotherapy for reflux after esophageal surgery
Effect of Physiotherapy on the Usage of Proton Pump Inhibitors and Changes in the Pressure of the Lower Esophageal Sphincter in Patients With Achalasia After Per Oral Endoscopic Myotomy
NA · Institute for Clinical and Experimental Medicine · NCT05326113
This study is testing if physiotherapy can help people who have reflux after esophageal surgery feel better and possibly reduce their need for medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine (other gov) |
| Locations | 1 site (Prague 4, Prague) |
| Trial ID | NCT05326113 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of physiotherapy on patients who experience reflux symptoms following per-oral endoscopic myotomy (POEM) for esophageal achalasia. It aims to strengthen the diaphragm and lower esophageal region to potentially reduce the need for proton pump inhibitors (PPIs) in these patients. The study will involve 30 participants who will undergo follow-up examinations three months post-surgery to assess their reflux symptoms and the effectiveness of the physiotherapy interventions. Detailed guidelines for post-POEM treatment will also be developed based on the findings.
Who should consider this trial
Good fit: Ideal candidates are patients with esophageal achalasia who have undergone POEM and are experiencing reflux symptoms three months post-surgery.
Not a fit: Patients who had reflux symptoms prior to POEM or those with severe esophagitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce reliance on proton pump inhibitors and improve quality of life for patients experiencing reflux after POEM.
How similar studies have performed: While physiotherapy has shown effectiveness in treating gastroesophageal reflux disease, this specific application post-POEM is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague 4, Prague
- Institute for Clinical and Experimental Medicine — Prague 4, Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Kateřina Mádle — Charles University 2nd faculty of medicine, Prague, Czech Republic
- Study coordinator: Kateřina Mádle
- Email: katerina.madle@gmail.com
- Phone: 00420606613462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Reflux, Gastroesophageal, Achalasia, Esophagitis, Per-oral endoscopic myotomy, Reflux, Physiotherapy, Proton pump inhibitors, Diapraghm