HiatoGast 1: an exploring, semiblinded trial establishing a new endoscopical categorisation of axial hiatal hernias

INTRODUCTION: Axial hiatal hernias are a common incidental finding in endoscopical examinations, but reflux symptoms do not necessarily correspond to the presence of hiatal hernias. Diagnosing a reflux disease is difficult due to a leak of existing distinct criteria, especially in order to evaluate a surgical indication. Also a preoperative measurement of the hernia is necessary to choose between surgical options. METHODS AND ANALYSIS: We planned a semiblinded trial including a questionnaire and an oesophagogastroduodenoscopy afterwards. While the endoscopy is done, the hiatus oesophagi should be measured in inversion technique under maximum insufflation including length, width and herniated volume. A sample of 210 participants until December 2020 is determined to evaluate the primary endpoint: we look forward to evaluate the anatomical parameters of reflux and non-reflux participants. ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee on 12th February 2019, the data will bei published after closure of inclusion. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00016863).