Okada, Naoya http://orcid.org/0000-0002-1443-9191
Kinoshita, Yoshihiro
Nishihara, Shoji
Kurotaki, Takuma
Sato, Aya
Kimura, Kotaro
Kushiya, Hiroki
Umemoto, Kazufumi
Furukawa, Shotaro
Yamabuki, Takumi
Takada, Minoru
Kato, Kentaro
Ambo, Yoshiyasu
Nakamura, Fumitaka
Article History
Received: 10 January 2022
Accepted: 5 June 2023
First Online: 19 June 2023
Declarations
:
: Oral and written informed consent will be obtained for every participating patient by the treating surgeon. The study protocol (currently version 5.1) was approved by the Teine Keijinkai Hospital Ethics Committee on Research with Human Subjects. Amendments are managed by the Teine Keijinkai Hospital Ethics Committee on Research with Human Subjects in August 2021, and patient enrollment was started in September 2021. The PYNI-GAREREO trial was registered at the UMIN Clinical Trials Registry as UMIN000045104 (ExternalRef removed).
: After the patients have gained sufficient understanding from the explanation form approved by the Teine Keijinkai Hospital Ethics Committee on Research with Human Subjects, their written consent to participate in the conduction and publication of this study as research subjects will be obtained. We will be willing to provide a model consent form on request.
: The authors declare that they have no competing interests.