Haanappel, Anouck E. G.
Bellato, Vittoria
Buskens, Christianne J.
Armuzzi, Alessandro
van der Bilt, Jarmila D. W.
de Boer, Nanne K. H.
Danese, Silvio
van der Does de Willebois, Eline M. L.
Duijvestein, Marjolijn
van der Horst, Daniëlle
Pellino, Gianluca
Richir, Milan C.
Selvaggi, Francesco
Spinelli, Antonino
Vignali, Andrea
Rosati, Riccardo
Bemelman, Willem A.
Article History
Received: 30 October 2023
Accepted: 1 February 2024
First Online: 26 February 2024
Declarations
:
: This trial will be conducted according to good clinical practice guidelines and the principles of the Declaration of Helsinki. This study has been registered on NCT Govtrial registry under the identification numbers: ExternalRef removed and ExternalRef removed. The HAND2END has been evaluated and approved by the IRCCS San Raffaele Ethical Committee (EC-13/06/2022, version 2.0) in June 2022 and. The End2End study has been approved by the Medical Ethical Committee of the Amsterdam UMC, Amsterdam (Latest amendment MEC 2022.0533 version 3.0) in September 2022. The protocol is registered by the Dutch Central Committee on Research Involving Human Subjects (NL81981.018.22). The participating centres will submit to their local EC for approval. At the time of submission of this study protocol, the following hospitals received approval for participation and are therefore open for inclusion: Flevo Hospital (Almere, The Netherlands), IRCCS Humanitas Research Hospital (Milan, Italy), Vanvitelli Hospital of Naples (Naples, Italy). Written informed consent will be obtained from all participants after an explanatory interview.
: Written informed consent for publication of their clinical images was obtained from the patient. A copy of the consent form is available for review by the Editor of this journal.
: The authors declare no competing interests.