Chapter 8 194 effects and with random patient effects. In addition, data at each time point were compared with independent samples t tests, Mann-Whitney U test and Chi-square test depending on the variables. All p values were two-tailed and statistical significance was taken as a p value of less than 0.05. Multiple imputation for incomplete records was not needed because less than 5% of the data was missing. An interim analysis was not performed for this study. Results Between 10 December 2018 and 13 July 2021, 140 patients were randomized to PFPT (n=70) and a control group (postponed PFPT) (n=70). Baseline characteristics were similar between the 2 groups (Table 1). Table 1. Demographics at baseline Variable Total group (n=140) PFPT group (n=70) Postponed PFPT (n=70) Age, years mean (SD), (range) 44.5(11.1),(19-79) 44.2(10.7),(23-66) 44.7(11.6),(19-79) Gender, women/men, n(%) 72(51.4)/68(48.6) 37(52.9)/33(47.1) 35(50)/35(50.0) Duration of complaints (%) 0-2 months 2-6 months 6-12 months 12-36 months >3 years 12.1 22.9 14.3 22.1 28.6 12.9 18.6 12.9 24.3 31.4 11.4 27.1 15.7 20.0 25.7 Lokation of fissure (%) Anterior 14.3 12.9 15.7 Posterior 77.9 78.6 77.1 Other 7.9 8.6 7.1 After randomisation, 1 patient in the PFPT group and 2 patients in the postponed PFPT group withdrew after inclusion. 97 patients completed the 1-year follow-up, 48 women (49.5%), 49 men (50.5%) with a mean age of 44,4 ±11,6 (range 19-68). In total, 40 patients were lost of follow-up from baseline to 1-year follow-up. Details of the loss of follow-up, missing values and other surgery are shown in Figure 1. (CONSORT diagram). There were no reported negative side effects or serious adverse events in both groups.
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