About this trial
\- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult >18 years
Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
Disqualifiers
Patients with Type 1 & 3 ACHALASIA CARDIA
Patients with previous endoscopic or surgical treatment for achalasia
Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio > 1.5, platelet count < 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
Trial design
Parallel
Treatments tested in this trial
Per oral endoscopy myotomy
DevicePoem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of true reflux based on 24-hour pH impedence
Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
Integrated Relaxation Pressure (IRP) at High resolution manometry test
IRP in mm Hg measures pressure in the esophagus
Sponsors and contacts
Click on the lead sponsor to view all of their trials.