Clinical trial NCT05326113: The Effect of Physiotherapy on Post POEM Reflux
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reflux, Gastroesophageal
Achalasia
Esophagitis
Keywords: Per-oral endoscopic myotomy
Reflux
Physiotherapy
Proton pump inhibitors
Diapraghm
Achalasia
Lower esophageal sphincter
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2022-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The goal per-oral endoscopic myotomy (POEM) is to release a non-relaxing, often spastic lower esophageal sphincter (LES). During POEM an incision of the esophageal muscle layer (m.propria) is performed using the submucosal tunnel technique.

A complication of POEM is the development of reflux, which occurs in up to 50% of patients (within 12 months), with the occurrence of severe esophagitis being rare. However, patients are treated with proton pump inhibitors (PPIs) after POEM, either daily or on-demand. As a result, patients after POEM are regularly monitored for the possible development of symptomatic or asymptomatic reflux, which (if left untreated) can lead to the development of complications, including Barrett's esophagus, a known precancerous lesion.

The main reason for reflux in patients after POEM is an insufficient function of the LES, which is formed not only by the smooth muscle of the esophagus, but also by the skeletal muscle- diaphragm, which remains intact during the POEM itself. Together, these two structures form a major component of antireflux barriers. Since the crural part of the diaphragm is a skeletal striated muscle, it is a trainable muscle.

The study will involve 30 patients after POEM with diagnosed reflux. Three months after POEM patients undergo follow-up examinations using high resolution manometry, 24hours pH test for reflux and gastroscopy. Based on the results of the examination in the 3rd month after the POEM, those who meet the inclusion criteria, will be offered to participate in this study. Patients will be asked to fill in the quality of life questionnaire of patients after POEM and the validated questionnaire for patients with reflux disease. Patients will be randomized in 2 groups (15 in both arms, ratio 1:1), one group will undergo 4 months of physiotherapy treatment using PPI on demand, second group will be a control group undergoing standard treatment of reflux symptoms with PPI on demand.

This study will evaluate the effect of standard treatment of post-POEM esophageal reflux compared to the effect of physiotherapy using dynamic neuromuscular stabilization in post-POEM patients with esophageal reflux.

There is currently no study looking at the effect of physiotherapy in post-POEM patients, we believe this could be a beneficial study.

If this study demonstrates that physiotherapy alleviates the symptoms of post-POEM reflux, it could be one of the official methods of treatment for this group of patients and thus significantly increase their quality of life.

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

Primary outcomes:
measure: Comparison of proton pump inhibitor drugs usage in experimental and control group
timeFrame: 9-10 months
Secondary outcomes:
measure: Comparison of diagnostic examinations
timeFrame: 9-10 month
measure: Comparison of questionnaires
timeFrame: 9-10 months
Other outcomes:
Locations:
city: Prague 4
country: Czechia
facility: Institute for Clinical and Experimental Medicine
state: Prague
Study officials:
affiliation: Charles University 2nd faculty of medicine, Prague, Czech Republic
name: Kateřina Mádle
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
name: Jan Martínek
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
name: Zuzana Vacková
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University Faculty of Physical Education and Sport
name: Milan Martínek
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Pilsen, Czech Republic
name: Lucie Zdrhová
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University 2nd faculty of medicine, Prague, Czech Republic
name: Alena Kobesová
role: PRINCIPAL_INVESTIGATOR
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