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The Effect of Physiotherapy on Post POEM Reflux

NCT05326113 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-07

No results posted yet for this study

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.

Conditions

  • Reflux, Gastroesophageal
  • Achalasia
  • Esophagitis

Interventions

OTHER

Physiotherapy

After POEM, patient underwent physiotherapy consisting of diaphragmatic breathing and dynamic stabilization exercises and PPIs

DRUG

Control group

All patients will be treated with standard course of PPIs after POEM without physiotherapy.

Sponsors & Collaborators

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Principal Investigators

  • Kateřina Mádle · Charles University 2nd faculty of medicine, Prague, Czech Republic

  • Jan Martínek · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  • Zuzana Vacková · Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  • Milan Martínek · Charles University Faculty of Physical Education and Sport

  • Lucie Zdrhová · Department of Internal Medicine, Pilsen, Czech Republic

  • Alena Kobesová · Charles University 2nd faculty of medicine, Prague, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-08-18
Completion
2025-01-18

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326113 on ClinicalTrials.gov