Els van de Vijver

66 Human Subjects Protection The study was conducted according to the principles of the Declaration of Helsinki. The Medical Ethics Review Committee of the University Medical Center in Groningen (METc 2013/503) and Antwerp University Hospital (14/40/407) approved the study protocol. The legal guardian(s) of all participants, as well as children aged 12 and above, gave informed consent to use data generated by routine medical care. The investigators collected and recorded data in such a manner that subjects could not be identified, directly or through identifiers linked to the subjects. RESULTS Between September 2014 and September 2016, we prospectively included 354 children and teenagers in the CACATU cohort. Of these, 135 had overt rectal bloodloss or perianal disease, which justified immediate endoscopic evaluation for the presence of IBD. Fifteen patients were excluded as their stool samples arrived at the hospital laboratory after an unacceptable delay that may have caused calprotectin degradation.(14) A total of 204 patients were included for this ancillary study, of which 193 continued down the decision tree until a final diagnosis was made ( figure 1 ). Chapter 4 66

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