Statistical plan
tumour
SECONDARY, TUMOUR
The 2-year recurrence-free survival (primary outcome) and overall survival will be evaluated by Kaplan–Meier method and compared by the log rank test. Other secondary outcomes will be compared using the chi-squared test or Fisher’s exact test for categorical variables, and the Mann–Whitney All clinical data including patients’ demographics, operative details, tumour characteristics, and clinical outcome measure will be collected and centralized at the principal investigator’s centre using a password-protected web-based system to ensure confidentiality of personal information. Continuous clinical data monitoring will be performed by the principal investigator and co-investigators with the help of biostatisticians and research assistants. The data set will be kept confidential until the publication of trial results.