Text and Data Mining valid from 2020-03-23
Received: 12 October 2019
Accepted: 2 March 2020
First Online: 23 March 2020
Ethics approval and consent to participate
: Ethical approval was granted by the independent ethics committee of the Medical Faculty of the University of Heidelberg on 22 March 2019 (version 1.1; reference S-099/2019) including the patient information material and informed consent form. The ethics approval of other participating centres is currently sought. All protocol amendments must be reported to and approved by the participating independent ethics committees. All amendments will be communicated immediately to the participating trial sites. Informed consent will be obtained from all study participants prior to inclusion. It will be emphasised that participation is voluntary and that the patient is allowed to refuse further participation in the study whenever he/she wants to. The EXPELLIARMUS trial will be conducted in agreement with the current version of the Declaration of Helsinki. This study protocol has been written and the study will be conducted and analysed in accordance with relevant national and international rules and regulations including International Conference of Harmonisation of Good Clinical Practice (ICH-GCP) guidelines. This trial will be conducted with no external funding and was instead funded from in-house sources of the Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg. Financial support for covering the publication fees of this article was given by the Deutsche Forschungsgemeinschaft, the Baden-Württemberg Ministry of Science, Research and the Arts and by Ruprecht-Karls Universität Heidelberg within the funding programme “Open Access Publishing”.
: Not applicable.
: The authors declare that they have no competing interests.