An interventional study of Physiotherapy and Control group in Reflux, Gastroesophageal, Achalasia and Esophagitis, sponsored by Institute for Clinical and Experimental Medicine. Recruiting at 1 site in Czechia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Institute for Clinical and Experimental Medicine · Not applicable, Interventional, and Treatment
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.
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 30 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Physiotherapy
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.
Drug: Control group
After POEM, patient underwent physiotherapy consisting of diaphragmatic breathing and dynamic stabilization exercises and PPIs
All patients will be treated with standard course of PPIs after POEM without physiotherapy.
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
Time frame: 9-10 months
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.
Time frame: 9-10 month
Comparison of questionnaires
Evaluation of the Quality of life questionnaire of patients after POEM. Evaluation of the validated questionnaire for gastroesophageal reflux disease.
Time frame: 9-10 months
Plan to share: Undecided
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