Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

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

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

• 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

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