Govert Veldhuijzen

92 Chapter 5 RESULTS From September 2015 to December 2017 a total of 1035 patients were assessed for eligibility. Of those, 190 patients declined to participate for several reasons. (Figure 2.) A total of 845 patients underwent randomization in four hospitals. After randomization, 161 patients were excluded from further analysis for the following five reasons: missing data (n=35), premature withdrawal from the trial (n=34), not receiving a scheduled colonoscopy (n=5) an incomplete colonoscopy due to pain / stenosis (n=41) or absence of BBPS score (n=46). This resulted in 684 patients who were included in the ITT analysis population. In these patients, the age and gender were not significantly different amongst groups. A total of 497 patients were entered for the PP analysis. A total of 217 patients received nurse counselling while 280 patients were assigned to CBE. (See study flow chart, figure 3.) All patients included in the analysis had 100% adherence to nurse counselling and to the complete CBE. Of these 497 patients, 100% completed the baseline study forms at T1, with lower response rates on pre-colonoscopy (55.6%) at T2 and post-colonoscopy (47.3%) forms at T3. Baseline characteristics were not significantly different with respect to age, gender, educational level and ethnicity. Prior experience with colonoscopy was comparable in both groups, with 46.8% in the nurse group and 51.5% in the CBE group. (Table 1.)