Achalasia Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 18, 2025 |
Est. primary completion date | August 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Institute for Clinical and Experimental Medicine | Prague 4 | Prague |
Lead Sponsor | Collaborator |
---|---|
Institute for Clinical and Experimental Medicine |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of proton pump inhibitor drugs usage in experimental and control group | Rate of use of IPP and only Emanera 2x40mg (higher dose), 1X40mg (standard dose), or 1x40 mg in case of problems or completely discontinue IPP | 9-10 months | |
Secondary | Comparison of diagnostic examinations | The secondary outputs will be the results of high resolution manometry examinations, where we monitor changes in pressure in the lower esophageal sphincter area and esophageal motility. The positivity and reflux rate will be demonstrated by 24hours pH testing and evaluated according to the De Meester score. Gastroscopy to evaluate the absence or presence of esophagitis. | 9-10 month | |
Secondary | Comparison of questionnaires | Evaluation of the Quality of life questionnaire of patients after POEM. Evaluation of the validated questionnaire for gastroesophageal reflux disease. | 9-10 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01399476 -
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
|
N/A | |
Recruiting |
NCT06044155 -
redoPOEM : Failure of a First POEM
|
||
Recruiting |
NCT02989883 -
Clinical Outcomes of Peroral Endoscopic Myotomy
|
N/A | |
Terminated |
NCT02606578 -
Achalasia Patient Reported Outcomes
|
||
Recruiting |
NCT01793922 -
POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM)
|
N/A | |
Recruiting |
NCT01302288 -
Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
|
Phase 2 | |
Terminated |
NCT03875365 -
Institutional Outcome Data From Per-oral Plication of the Esophagus
|
||
Enrolling by invitation |
NCT02770859 -
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
|
||
Recruiting |
NCT05905016 -
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
|
||
Completed |
NCT01692106 -
A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia
|
N/A | |
Completed |
NCT01405469 -
Endoscopic Peroral Myotomy for Treatment of Achalasia
|
N/A | |
Completed |
NCT01402518 -
Per-Oral Endoscopic Myotomy
|
||
Not yet recruiting |
NCT00790465 -
Efficacy of Dark Chocolate in Achalasia Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT01799967 -
Minimally Invasive Surgery of the Gastro-esophageal Junction
|
||
Terminated |
NCT00604942 -
vMII for Measurement of Oesophageal Bolus Transport and Reflux
|
N/A | |
Recruiting |
NCT06405412 -
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
|
N/A | |
Not yet recruiting |
NCT06042127 -
POEM-F for Achalasia International Study
|
N/A | |
Completed |
NCT04752670 -
ConMed Beamer Study
|
||
Completed |
NCT02314741 -
Peroral Endoscopic Myotomy (POEM) for Esophageal Motility
|
N/A | |
Completed |
NCT01933373 -
A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
|
N/A |