Skip to main content
OpenTrials
Completed

NCT Number: NCT05500196

Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, 500082, India

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Per Oral Endoscopy Myotomy (POEM)

Device

POEM is a form of natural orifice transluminal endoscopic surgery that is completed by creating a submucosal tunnel in the lower part of esophagus to reach the inner circular muscle bundles of the LES to perform myotomy, while preserving the outer longitudinal muscle bundles. The result is decreased resting pressure of the LES, facilitating the passage of ingested material.

Primary outcomes

  1. Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux

    Time frame: 6 months

    incidence of reflux esophagitis >grade B in cases with standard and extended gastric myotomies after POEM

  2. Ph metry test for gastroesophageal reflux

    Time frame: 6 months

    Significant esophageal acid exposure(> 6%)

Secondary outcomes

  1. Symptoms of Gastro esophageal reflux disease

    Time frame: 6 months

    Health related quality of life questionaires or scores in numericals

  2. High resolution manometry parameters(LES pressures and IRP)

    Time frame: 6 months

    lower esophageal sphincter pressure will be assesed by mmhg, integrated resting pressure in mmhg units

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Impact of Gastric Length of Myotomy During Poem on Gastroesophageal Reflux : A Randomized Controlled Trial

Acronym: IGL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.