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Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

This observational study will be conducted among 43 patients of both sexes in each group Study participants will be of the age more than 18 years

  • STUDY PROCEDURE-Pre-defined technique to avoid bias and confounding due to multiple factors
  • All the poem procedures will be performed by posterior route
  • Preservation of sling fibers will be attempted in all the cases to avoid heterogeneity
  • Length of esophageal myotomy will be kept constant (4-6cm)
  • Double scope technique will be utilized to confirm the gastric extent of myotomy

First evaluation at 1-month: based on Symptoms

• Second evaluation: at 6 months by

  • Objective evaluation: UGI endoscopy, High resolution manometry, Timed barium swallow
  • Eckardt score, GERD-HRQL
  • 24-hour pH study with manual readings

Description

• The primary outcome of the study is the incidence of significant reflux esophagitis (≥grade B) in cases with standard and extended gastric myotomies at 6 months after POEM

Secondary outcomes:

  • Significant esophageal acid exposure (>6%) as defined by the revised Lyon consensus
  • Symptoms of GERD (GERD HRQL)
  • Clinical efficacy (Eckardt score≤3)
  • Esophageal emptying at 5 minutes
  • High resolution manometry parameters (LES pressures and Integrated relaxation pressure in mmhg units)
  • All the secondary outcomes will be assessed at 6 months after poem procedure
    Eligibility

Eligible cases with idiopathic achalasia (type I and II) will be enrolled in the study and randomized (1:1 ratio) in two groups according to the length of gastric myotomies

INCLUSION CRITERIA :

  • Idiopathic achalasia (type I and II)
  • Age ≥18 years
  • Willing to provide informed consent and comply with the study protocol

Exclusion criteria

  • Ineligibility for POEM procedure
  • Spastic esophageal motility disorders
  • Presence of esophageal diverticulum and hiatal hernia
  • Prior hellers myotomy with or with out fundoplication

Eligibility

Inclusion Criteria:

  • Idiopathic achalasia (type I and II)
  • Age ≥18 years
  • Willing to provide informed consent and comply with the study protocol

Exclusion Criteria:

  • Ineligibility for POEM procedure
  • Spastic esophageal motility disorders
  • Presence of esophageal diverticulum and hiatal hernia
  • Prior hellers myotomy with or with out fundoplication

Study details

Gastric Reflux

NCT05500196

Asian Institute of Gastroenterology, India

26 January 2024

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