RecruitingNot ApplicableNCT06870630

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


Sponsor

Asian Institute of Gastroenterology, India

Enrollment

158 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Adult \>18 years
  • Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.

Exclusion Criteria2

  • Patients with Type 1 \& 3 ACHALASIA CARDIA
  • Patients with previous endoscopic or surgical treatment for achalasia

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Interventions

DEVICEPer 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

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NCT06870630


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