Shrestha, Niti
Wu, Liang
Wang, Xiaodi
Jia, Wenqing
Luo, Fang
Funding for this research was provided by:
Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (ZYLX201708)
Article History
Received: 25 December 2019
Accepted: 2 April 2020
First Online: 5 May 2020
Ethics approval and consent to participate {24}
: This study design was approved by the IRB of Beijing Tiantan Hospital (KY 2019-112-02-1) and is in accordance with the World Medical Association’s Declaration of Helsinki. All participants will be provided with a written, informed consent form prior to the surgery that will describe in detail all aspects of the study and withdrawal process. Patients considered eligible for participation in the study will be given a verbal explanation of the written informed consent. All participants will have sufficient time to decide whether to participate in this study, and will be instructed that they are free to obtain any relevant information regarding the study at any point throughout the study. If the patient is willing to participate, written informed consent will be obtained before the surgery. Participants will be allowed to withdraw their consent or discontinue participation without any restriction at any time throughout the study. This PRE-EASE trial protocol has been designed according to the Consolidated Standards of Reporting Trials (CONSORT) recommendations [CitationRef removed], and the protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement [CitationRef removed].
: These are available from the corresponding author on reasonable request, if the patients' consent to have their data published.
: The authors declare that they have no competing interests.