Kaiser, Joerg
Niesen, Willem
Probst, Pascal
Bruckner, Thomas
Doerr-Harim, Colette
Strobel, Oliver
Knebel, Phillip
Diener, Markus K.
Mihaljevic, André L.
Büchler, Markus W.
Hackert, Thilo http://orcid.org/0000-0002-7012-1196
Article History
Received: 14 October 2018
Accepted: 13 May 2019
First Online: 7 June 2019
Ethics approval and consent to participate
: The trial protocol was approved by the ethics committee of the University of Heidelberg (Ethikkommission Medizinische Fakultät Heidelberg, S-675/2017) and the trial was registered (DRKS00013763; UTN: U1111-1207-3031). Before inclusion in the PANDRA II trial, patients will be informed both orally and in writing about all relevant aspects of the trial (e.g., the aims, methods, the anticipated benefits, potential risks of the study, and the discomfort it may entail). Patients must be at least 18 years of age and provide written informed consent. They have to be able to understand character and individual consequences of the clinical trial. The patients’ free decision to participate will be documented by signature on the informed consent form. The trial will be conducted at the Clinical Trial Center (KSC) of the Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg in the context of Good Clinical Practice and in accordance with the Declaration of Helsinki. All patient-related information is subject to medical confidentiality and to medical secrecy, the European General Data Protection Regulation (DSGVO — Datenschutzgrundverordnung), the Federal Data Protection Act (Bundesdatenschutzgesetz), and the State Data Protection Act (Landesdatenschutzgesetz). Third parties will not have any insight into original data.
: Not applicable.
: The authors declare that they have no competing interests.