Houben, Philipp http://orcid.org/0000-0001-5234-732X
Hinz, Ulf
Knebel, Phillip
Diener, Markus K.
Mehrabi, Arianeb
Schemmer, Peter
Funding for this research was provided by:
Heidelberger Stiftung Chirurgie (2016/74)
Article History
Received: 14 January 2018
Accepted: 29 May 2019
First Online: 10 June 2019
Ethics approval and consent to participate
: The trial is carried out in accordance with the current version of the declaration of Helsinki from 2013. The clinical trial will be conducted in accordance with the European Union’s recommendations on “Good Clinical Practice (GCP)”.Prior to the start of the trial the study protocol was submitted to the ethical review committee of the medical faculty of the University Heidelberg for ethical consultation. The respective affirmation (S-193/2015) was received on May 18th, 2015. All relevant changes in the protocol will be announced to the ethical review committee.The participation in the trial is voluntary. The participation is not awarded financially or implies any other benefits for the patient.The patients can withdraw their consent to participate in the trial at any time without statement of reasons or adverse consequences in the further course of their medical treatment.All personal patient information is subject to professional discretion, according to the German federal data privacy protection law (Bundesdatenschutzgesetz, BDSG). All data interpretation and transmission is only done pseudonymous. None of the data will be made available to a third party.Before the participation in the trial all patients are informed about the nature, course and risks of the trial in written and oral form by an investigator. All potential beneficial and hazardous effects or trial related risks will be explained. The patients’ consent to participation is documented on a written informed consent form by signature.
: Not applicable.
: The authors declare that they have no competing interests.