Statistical analysis
infection, wound infection, pneumonia
PNEUMONIA, WOUND INFECTION, INFECTION, SECONDARY, LEAKAGE, REGRESSION, INFECTION TOE
The primary endpoint was peristomal wound infection rate 2 weeks after the procedure. The secondary endpoint includes wound positive culture rate, blood culture positive rate, pneumonia, variation of white blood cell, and CRP, PEG, procedure time and stomal leakage rate. The Fisher exact test or a χ2-test with Yates’ correction was used to compare categorical variables when appropriate, and the Mann-Whitney U-test was used to compare continuous variables. The risk factors of peristomal wound infection were compared using the Logistic regression model.The variables with statistical significance (P < 0.05) or approximate significance (P < 0.1) by univariate analysis were subjected to a multivariate analysis using a forward stepwise logistic regression model. A two-tailed p-value of less than 0.05 was considered statistically significant. The diagnostic accuracy of delta CRP was examined by the receiver operating characteristic curve (ROC curve). The best cut-off value of each indicator was chosen based on Youden’s index. The sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were calculated based on the cut-off point. All statistical analyses were carried out using IBM SPSS Statistics for Windows, version 23.0 (IBM Corp., Armonk, New York, USA). Peristomal infection within 2 weeks after PEG implantation was the outcome measurement to estimate the sample size for this study. Assuming an alpha risk of 0.05, a beta risk of 0.8, and peristomal infection to be 5% in the Betadine group and 20% in the control group according to previous studies [