Sample size and statistical analysis
SURGICAL COMPLICATIONS
The primary objective of this study was to determine whether taTME was non-inferior to standard LAR in terms of the proportion of subjects that achieve complete or near-complete mesorectal excision. With a sample size of 100, the one-sided binomial test will reject the null hypothesis that the success rate is ≤ 80% if the study procedure leads to efficacy of the total mesorectal excision for 87 or more subjects. This design achieves a power of 87% using one-sided binomial test for non-inferiority with 5% type 1 error assuming the true success rate is 90%. Patient demographic, disease-related, treatment-related, operative characteristics as well as pathologic outcomes and 90-day surgical complications were summarized for continuous variables as median and first and third quartiles, Q1–Q3, and for categorical variables as counts and percentages. Distributions of categorical variables were compared among group using the 