Full-thickness vs selective myotomy during Peroral Endoscopic Myotomy (POEM) in achalasia. Results of a double-blind, randomized clinical trial
Abstract
Achalasia is defined as a functional obstruction of the esophagus due to impaired relaxation of the lower esophageal sphincter (LES) with either absent or spastic peristaltic activity of the esophagus. Peroral Endoscopic Myotomy (POEM) traditionally involves an esophageal full-thickness myotomy. A significant side effect is gastroesophageal reflux.
This study investigates if myotomy of the lower esophageal circular muscle is associated with reduced risk of gastroesophageal reflux while still maintaining similar control of mechanical symptoms compared to traditional full-thickness myotomy?
55 patients (29 males, median age 44 years) with achalasia were randomized to either full-thickness (n=28) or selective myotomy (n=27). The groups were comparable in characteristics and disease-specific variables. Swallowing-related symptoms, reflux symptoms (GSRS) and quality of life (SF-36) were recorded before and at defined times postoperatively.
Preoperatively median Eckardt score (7 range; 3 – 11 in both groups) or the reflux item within the GSRS (2 and 1.5 (1 – 5)) in the full thickness and selective myotomy groups, respectively, did not differ. 12 months postoperatively, a median Eckardt score of 2 was reported in both groups (range; 0 – 3 vs 0 – 5) Reflux item in GSRS (median 1.5; range 1 – 4) as well as the mental and physical dimensions in the SF-36 did not differ between groups.
In this study, reflux symptoms and Eckhardt one year after full-thickness and selective endoscopic…
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: 55 participants or records.
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