The Effect of Physiotherapy on Post POEM Reflux
Reflux, Gastroesophageal, Achalasia, Esophagitis
About this trial
This is an interventional treatment trial for Reflux, Gastroesophageal focused on measuring Per-oral endoscopic myotomy, Reflux, Physiotherapy, Proton pump inhibitors, Diapraghm, Achalasia, Lower esophageal sphincter
Eligibility Criteria
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
- pregnancy
- known allergy or intolerance of proton pump inhibitor drugs
- other circumstances preventing participation in the study
- Inability to obtain informed consent
Sites / Locations
- Institute for Clinical and Experimental MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Physiotherapy
Control group
Patients will undergo physiotherapy and will be regularly examined by an assigned physician. Initial physiotherapy will last 60minutes, other therapies will last 30minutes. Physiotherapy will aim on diaphragmatic breathing and dynamic neuromuscular stabilization exercises. In the 1st month, the patient attends physiotherapy once a week In the 2nd, 3rd and 4th month, the patient attends physiotherapy once every 14 days. Symptomatic patients will take PPIs based on the recommendation of the treating physician who will recommend a dose of PPIs. Used PPIs will be Emanera 1x40mg (standard dose), 2x40mg (higher dose) or 1x40mg on demand. During the follow-up period, patients may, in agreement with the attending physician, reduce the dose of PPIs (from twice a day to once a day, from once a day to an "on-demand" regime or discontinue them altogether). The use of PPIs will be accurately documented.
Control group will undergo standard treatment of reflux with PPIs and will be regularly examined by an assigned physician. Symptomatic patients will take PPIs based on the recommendation of the treating physician who will recommend a dose of PPIs. Used PPIs will be Emanera 1x40mg (standard dose), 2x40mg (higher dose) or 1x40mg on demand. All patients with esophagitis LA A/B/C will be treated with IPP-Emanera 1x40mg for at least 6 weeks at the start of the study. During the follow-up period, patients may, in agreement with the attending physician, reduce the dose of PPIs (from twice a day to once a day, from once a day to an "on-demand" regime or discontinue them altogether). The use of PPIs will be accurately documented.