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
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
Kateřina Mádle
katerina.madle@gmail.com
00420606613462
Backup
Jan Martínek
jan.martinek@volny.cz
00420723708839
Time Frame
Start Date: 2021-10-31
Estimated Completion Date: 2025-01-18
Participants
Target number of participants: 30
Treatments
Experimental: Physiotherapy
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.
Active_comparator: Control group
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.
Sponsors
Leads: Institute for Clinical and Experimental Medicine

This content was sourced from clinicaltrials.gov