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Article History

Received: 7 April 2021

Accepted: 6 November 2023

First Online: 18 January 2024

Declarations

:

: The trial was approved by the IRB of Beijing Tiantan Hospital, Capital Medical University (approval number: KY 2019–005-05). Before surgery, when the patients meet the eligibility criteria, the researcher will explain the study plan and all potential risks to the participants and their authorized surrogates. Then, the participants will be required to sign an informed consent before enrollment. Throughout the research process, participants would be free to withdraw their consent or discontinue participation at any time without any restrictions. The reasons and corresponding circumstances will be recorded in the case report form (CRF). Participants will be asked if their data can be used in a specific research project after they have signed the informed consent form. This trial will not involve the collection of biological specimens for storage.The relevant private information of the involved patients, such as name, home address, and contact phone number, will be kept confidential. The information paper will be locked in a safety box and the electronic information will be stored in an encrypted electronic database with restricted access by the principal investigator (PI) who will sign the confidential disclosure agreement. Data and information will not be printed or transmitted to any auxiliary media and will record the date and time when team members accessed the database. Each patient will be assigned a unique study identifier that will only appear on the data and documents during evaluation or statistical analysis. In addition, all original records, such as informed consent and CRF, will be destroyed according to hospital standards.

: The authors declare that they have no competing interests.