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Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
Sponsor: Asian Institute of Gastroenterology, India
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2023-11-29
Completion Date
2025-07-30
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India