Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05326113
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2022-03-15
Brief Title:
The Effect of Physiotherapy on Post POEM Reflux
Sponsor:
Institute for Clinical and Experimental Medicine
Organization:
Institute for Clinical and Experimental Medicine
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mpropria 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 Barretts 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 11 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
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 Barretts 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None