Conventional Versus Oblique Fiber Sparing Endoscopic Myotomy for Achalasia Cardia: A randomized controlled trial
Abstract
BACKGROUND AND AIM
Gastroesophageal reflux disease (GERD) is common after per-oral endoscopic myotomy (POEM). Selective sparing of oblique fibers may reduce the incidence of reflux esophagitis after POEM. In this study, we aim to compare the incidence of GERD between conventional myotomy (CM) versus oblique fiber sparing (OFS) myotomy in cases with achalasia.
METHODS
Eligible patients with type I and II achalasia who underwent POEM from Jan 2020 to October 2020 were randomized into two groups (CM and OFS). Exclusion criteria were: type III achalasia, sigmoid esophagus and history of Heller's myotomy. Primary outcome of the study was incidence of reflux esophagitis (≥grade B) in the two groups. Secondary outcomes included reflux symptoms, esophageal acid exposure, clinical success and adverse events.
RESULTS
115 patients were randomized into CM (58) and OFS (57) groups. POEM was technically successful in all patients. Overall, reflux esophagitis was found in 56 (48.7%) patients. The incidence of ≥grade B esophagitis was similar in both groups (CM 25.9% vs OFS 31.6%, p=0.541). Mean number of reflux episodes (48.2±36.6 vs 48.9±40.3, p=0.933), increased esophageal acid exposure >6% (45.5% vs 31.7%, p=0.266) and high DeMeester scores (38.6% vs 41.5%, p=0.827) were similar in both groups. There was no difference in the rate of symptomatic reflux (GerdQ>7) and use of proton pump inhibitors at 1-year.
CONCLUSION
Sparing of sling fibers has no significant impact on the incidence of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 115 participants or records.
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