Udelnow, Andrej
Hecht, Verena
Buschmann, Ivo
Wilbrandt, Catharina
Barth, Udo
Meyer, Frank
Halloul, Zuhir
Funding for this research was provided by:
Universitätsklinikum Magdeburg
Article History
Received: 10 November 2020
Accepted: 13 November 2020
First Online: 4 December 2020
Compliance with ethical guidelines
:
: A. Udelnow, V. Hecht, I. Buschmann, C. Wilbrandt, U. Barth, F. Meyer, and Z. Halloul declare that they have no competing interests. This includes, but is not limited to, any financial relationship with regard to the research presented.
: The study was performed according to the guidelines and ethical standards of the Declaration of Helsinki for Biomedical Research from 1964 by the World Medical Association and its further amendments, the policy of the local institutional ethic committees, and according to the requirements of Good Clinical Research and Good Clinical Practice. Data generation, documentation, and evaluation was performed according to prerequisites of data protection law of the German district Saxony-Anhalt and according to federal law. With regard to the study concept, it can be stated that a (potential) danger for study participants can be definitely excluded. There is no imponderable risk or side effect for the patient as it may become possible in the use of any medication. Each patient signed an informed consent form prior to (i) surgery, including appropriate explanation of the surgical intervention and potential complications, and (ii) generation and documentation of data in the patient data registry.