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Article History

Received: 15 October 2024

Accepted: 4 December 2024

First Online: 14 January 2025

Declarations

:

: An ethics approval was obtained from the responsible ethics committees in Germany and in Spain before patient recruitment started. For the Spanish Clinic (Comité Ètic d’Investigació de la Fundació Unió Catalana Hospitals, Barcelona, Spain, project number CEI 23/39, approval date 18 April 2023) and German clinic (Ethics Committee “Ethik-Kommission bei der Landesärztekammer Hessen, Frankfurt am Main, Germany, project number: 2023–3261-evBO, approval date 17 June 2023). Before participation in the study, all included patients will provide their written informed consent. The study is carried out in line with the principles of the Declaration of Helsinki and in compliance with Good Clinical Practice. The Data Protection Law applies and the clinics will ensure the preservation of the pseudonymisation of the participants by using a unique patient identification and randomisation code. The study protocol is written in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and SPIRIT guidelines. The SPIRIT checklist is provided as additional file.

: Each participant will provide a written informed consent that her anonymised data can be used for publications in scientific journals. Images or videos of individual participants will not be created and used.

: PB is an employer of Aesculap AG. Amadeus Hornemann gives annual surgery courses for Aesculap AG. The other authors declare no competing interest.