Follow-up and outcome measures
achalasia, GERD
GASTRO-OESOPHAGEAL REFLUX DISEASE, ADVERSE EVENTS, ACHALASIA, GERD, ADVERSE EVENT, SECONDARY, EVENTS
All patients were systematically followed for 6 months after the procedure.Post-procedural data included length of hospital stay, delayed adverse events, symptoms and Eckardt score, symptoms of gastro-oesophageal reflux disease (GERD), medication (e.g. proton pump inhibitors) at 3 and 6 months and manometry data at 6 months.The main study endpoint was the comparison of the efficacy of POEM as a treatment of achalasia between the POEM1 and POEM2 groups. The main outcome measure was the proportion of clinical success at 6 months, defined as an Eckardt score of ≤ 3 [The secondary endpoints were the technical success and procedural, post-procedural and late POEM-related morbidity. The secondary outcome measures were the comparison between the two groups for completeness of the procedure, defined as a successful myotomy and tunnel closure, duration of the procedure adverse events that occurred intra-procedure, post-procedure or late after the procedure, and length of hospital stay.Adverse events were graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon [Adverse events were considered mild if they led to a prolonged hospitalization of ≤ 3 nights. They were considered moderate if they led to a prolonged hospitalization of 4–10 nights, an admission to an intensive care unit for one night or if a repeated endoscopy or an interventional radiology treatment was needed. Adverse events were considered severe if they led to a prolonged hospitalization of more than ten nights, an admission to an intensive care unit for more than one night, if a surgical treatment was required or if these events led to a permanent disability. Post-procedural adverse events occurred within 14 days and late adverse events occurred more than 14 days after the POEM.