We conducted a prospective, multicenter, endoscopist blinded, non-inferiority randomized controlled trial. The primary outcome was adequate bowel preparation, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcome measures were sickness absence due to outpatient clinic visit, patient anxiety / satisfaction scores and information re-call. We included patients in four endoscopy units (rural, urban, and tertiary).
We screened 1035 eligible patients and randomized 845. After evaluation, 684 were included in the intention-to-treat (ITT) group. Subsequently, 497 patients were included in per-protocol (PP) analysis, 217 in nurse counselling and 280 in the CBE group. Baseline characteristics were similarly distributed among groups. In PP analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse counselled patients (94%, 204/217), with a difference of -0.8% [95% CI [- 5.1; 3.5]%. Non-inferiority was confirmed in the ITT population. Sickness absence was significantly more frequent in nurse counselled patients (28.0% vs 4.8%). In CBE patients, 21.5% needed additional information, resulting in 3.0% extra outpatient visits.
CBE is non-inferior to nurse counselling in terms of bowel preparation during colonoscopy, with lower patient sickness leave. CBE may serve as an efficient educational tool informing patients before colonoscopy in routine clinical practice.
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