The Effect of Physiotherapy on Post POEM Reflux (NCT05326113) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Physiotherapy on Post POEM Reflux
Czechia30 participantsStarted 2021-10-31
Plain-language 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 effect of the surgery. Patients are then in need to use proton pump inhibitor drugs as a long term treatment of the reflux symptoms.
Physiotherapy aimed on the strengthening of diaphragm and lower esophageal region is effective in gastroesophageal reflux disease. Therefore we are expecting positive effect of physiotherapy in post POEM patients with reflux symptoms and the possible reduction of PPI drug usage need.
The aim of the study is to objectify the effect of physiotherapy, to describe in detail the used physiotherapeutic techniques and to develop practical guidelines for the treatment of patients after POEM with GERD.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Comparison of proton pump inhibitor drugs usage in experimental and control group
Timeframe: 9-10 months
Trial details
NCT IDNCT05326113
SponsorInstitute for Clinical and Experimental Medicine