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Post-POEM GERD in Patients Undergoing Conventional Versus Oblique Fibers Sparing Posterior Myotomy for Achalasia Cardia

NCT04229342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-04-19

No results posted yet for this study

Summary

In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.

Conditions

  • GERD

Interventions

PROCEDURE

Per-oral endoscopic myotomy

Per-oral endoscopic myotomy (POEM) is an endoscopic modality for the management of achalasia cardia. In this study, we will evaluate the impact of two different techniques of posterior POEM on the incidence of gastroesophageal reflux disease (GERD). Posterior POEM will be performed using the standard technique. The myotomy beyond the GEJ will be different in the two groups. In one group, the sling fibers will not be spared from dissection and in the second group, the sling fibers will be selectively spared from myotomy.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr. Vincy Chandran, MBBS,MD · Asian Institute of Gastroenterology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2020-07-16
Completion
2020-10-06

Countries

  • India

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 NCT04229342 on ClinicalTrials.gov