Document is current

Article History

Received: 26 September 2023

Accepted: 2 January 2024

First Online: 3 February 2024

Declarations

:

: The sponsor and the investigating surgeons agree that this research will be carried out in accordance with Law No. 2004-806 of August 9, 2004, as well as in accordance with Good Clinical Practices (I.C.H. version 4 of May 1, 1996, and decision of November 24, 2006) and the Declaration of Helsinki. The research is conducted in accordance with this protocol, except in emergency situations requiring the implementation of specific therapeutic acts. The investigating surgeons will respect all aspects of the protocol, in particular, with regard to the collection of consent and notification and follow-up of SAEs. The present study was approved by the committee I Sud-Méditerranée of the CPP (2022-A00874-39) on 12/08/2022.The patient will be informed orally and in writing through the information note about the objective of the research; the progress and duration of the study; the benefits, potential risks and constraints of the study; and the opinion given by the CPP (art. L.1122-1 CSP). The information note is supplemented with the information necessary to comply with the regulations on the protection of personal data (GDPR). The investigating surgeon must specify to the patient that they are totally free to accept or refuse their participation in the research and that they retain the right to withdraw from the study at any time for any reason without causing any prejudice, in particular, professional one. The patient’s participation in the protocol will be mentioned in their medical file at the time of the inclusion visit. All patients will provide written informed consent signifying their agreement to participate in the research before any study-specific assessment or procedure is performed (Art.L1122-1-1 CSP). No compensation is provided for the participation in this study.

: Not applicable.

: The authors declare that they have no competing interests.