Study population
achalasia
ACHALASIA, MAY, RECRUITMENT
Consecutive patients with achalasia who underwent POEM over 5 years, from May 2013 to April 2018, were assessed for study eligibility. We performed a prospective randomized participant- and assessor-blind, sham-controlled study to evaluate the effectiveness of EFTP using a new EFTP device (GERDx; G-SURG GmbH, Seeon-Seebruck, Germany) in post-POEM patients from June 2019 to August 2021. The first and last patients were enrolled in June 2019 and February 2021, respectively, and the follow-up of the last patient was in August 2021. The study protocol was reviewed and approved by the Institutional Ethics Committee (IEC/OA-39/19). Written informed consent was obtained from each patient before enrollment. The co-investigators who collected the data (G.P., A.V.) and analyzed the data (P.J.) were unaware of the study group assignments. The trial was registered in a publicly accessible database before recruitment of the first patient.