Gastric Reflux Clinical Trial
Official title:
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 ;
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