Tagkalos, E.
van der Sluis, P. C.
Berlth, F.
Poplawski, A.
Hadzijusufovic, E.
Lang, H.
van Berge Henegouwen, M. I.
Gisbertz, S. S.
Müller-Stich, B. P.
Ruurda, J. P.
Schiesser, M.
Schneider, P. M.
van Hillegersberg, R.
Grimminger, P. P.
Funding for this research was provided by:
Intuitive Surgical (2019 grand cycle)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Article History
Received: 22 April 2021
Accepted: 13 September 2021
First Online: 26 September 2021
Declarations
:
: This study is conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines The independent ethics committee of the University Medical Center of the Johannes Gutenberg University, Mainz, Germany has approved the study (Nr: 2019–14049). Any modifications to the protocol which may impact on the conduct of the study, or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment must be approved by the ethics committee prior to implementation. Written informed consent will be obtained from all participating patients.
: Written informed consent for data publication will be obtained from all participating patients. The consent form states that the details/images/videos (the images of the study will be unidentifiable) will be freely available on the internet and may be seen by the general public.An interim report as well as the primary outcome papers would be generated. PI and SI as well as the lead investigators will revise the data for publication and the steering committee will control the final draft. After the end of the study the release of the results will be controlled by the steering committee after PI, SI and lead investigators have revised the later data for publication. Any investigators that will fulfil authorship criteria will have authority over manuscript content. Professional writers would not be used.
: RvH, JPR and PPG are proctors for Intuitive Surgical Inc.The study received funding by Intuitive Surgical Inc. Apart from the funding, which is listed detailed below, Intuitive Surgical Inc. did not take part in any steps of the study design and have not authority in any activities concerning the study (execution, analyses as well as interpretation of the data) and the followed publications. The study protocol therefor has not undergone peer-review by the funding body.