Chapter 5 132 Main study outcomes Primary outcome The primary outcome measurement is tone at rest (μV) during s-EMG registration of the pelvic floor before and after therapy. Secondary outcomes consist of prevalence of pelvic floor dysfunction in CAF; relation between CAF and other pelvic floor dysfunctions, pelvic floor muscle function before and after PFPT; VAS-pain during defecation before-and after PFPT, healing of the fissure (complete re-epithelisation), quality of life (the Short-Form 36 Health Survey, RAND-36) and complaint reduction with a proctology specific patient reported outcome measurement (Proctoprom) before and after PFPT. The effect analyses adhere to the design of an RCT and measures at baseline, after 8, 20 weeks and 1-year follow-up. Statistical analysis Data are analysed using Statistical Packages for Social Sciences (SPSS, Chicago, II, USA, version 26.0). Descriptive methods will be used to assess quality of data, homogeneity of treatment groups and endpoints. Normality of the data will be analysed with histograms. Data are presented using mean (SD), median (min-max) for the numeric and non-normal variables and frequency (percentages) for categorical variables. A paired t-test or Wilcoxon signed-rank test will be used to compare continuous variables within groups. The two-sample t-test or the Mann-Whitney-U test for quantitative data and the chi-square test or Fisher’s exact test for qualitative data will be performed to test differences between groups. The analysis of covariance (ANCOVA) is used to assess the effect of intervention and to control for baseline measures and confounders. Repeated measure analysis of variance (ANOVA) will be performed for the different time points assessments between groups and interaction between groups and observed time. All p-values will be two-tailed and statistical significance will be taken as a p-value of less than 0.05. In case of incomplete records, missing data will be imputed using multiple imputation to accommodate intention to treat analysis when more than 5% data is missing. The number of imputations will be defined by the percentage of incomplete patients with respect to the variables of interest. An interim analysis will not be performed for this study.
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