Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

Study Overview
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Brief Summary
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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

Detailed Description
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• 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

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

Conditions
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Gastric Reflux

Intervention / Treatment
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* Device: Per Oral Endoscopy Myotomy (POEM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myotomy length<br>Extended myotomy >2.5cm | Device: Per Oral Endoscopy Myotomy (POEM)<br>* 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.<br>|
| MYOTOMY LENGTH<br>Extended myotomy>4 | Device: Per Oral Endoscopy Myotomy (POEM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux | incidence of reflux esophagitis >grade B in cases with standard and extended gastric myotomies after POEM | 6 months | 
| Ph metry test for gastroesophageal reflux | Significant esophageal acid exposure(> 6%) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Gastro esophageal reflux disease | Health related quality of life questionaires or scores in numericals | 6 months | 
| High resolution manometry parameters(LES pressures and IRP) | lower esophageal sphincter pressure will be assesed by mmhg, integrated resting pressure in mmhg units | 6 months |