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Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

NCT05500196 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2024-07-30

No results posted yet for this study

Summary

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

Conditions

  • Gastric Reflux

Interventions

DEVICE

Per Oral Endoscopy Myotomy (POEM)

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Zaheer Nabi, MBBS MD DNB · ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS

Eligibility

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

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2024-01-10
Completion
2024-07-25

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 NCT05500196 on ClinicalTrials.gov