Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Per oral endoscopy myotomy: Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.

Study summary

\- 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

Primary outcome measure(s)

• Incidence of true reflux based on 24-hour pH impedence — 3 months
  Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
• Integrated Relaxation Pressure (IRP) at High resolution manometry test — 3 months
  IRP in mm Hg measures pressure in the esophagus

Trial sites (1)

More Asian Institute of Gastroenterology, India trials in India

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