The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease. The main question it aims to answer is: How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations? Researchers will compare with patients examined with colonoscopy and a small bowel examination. Participants will: * Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * Have their electronic medical records checked to see if a diagnosis has been made * Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
165
Panenteric capsule endoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation.
MRI of the small bowel
Capsule endoscopy of the small bowel
Esbjerg Hospital - University Hospital of Southern Denmark
Esbjerg, Denmark
RECRUITINGOdense University Hospital
Odense C, Denmark
RECRUITINGOdense University Hospital - Svendborg Hospital
Svendborg, Denmark
NOT_YET_RECRUITINGLillebaelt Hospital Vejle - University Hospital of Southern Denmark
Vejle, Denmark
RECRUITINGSkåne University Hospital
Malmo, Sweden
NOT_YET_RECRUITINGDiagnostic completeness
Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations
Time frame: Immediately after initial diagnostic procedure
Feasibility of pan-enteric CE
Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided
Time frame: After completion of follow-up (12 months)
Additional examinations
Need for additional examinations in the two randomization arms
Time frame: After completion of follow-up (12 months)
Safety
Number of severe adverse events
Time frame: After completion of follow-up (12 months)
Time to diagnosis
Time from referral or first diagnostic procedure to final diagnosis and treatment
Time frame: After completion of follow-up (12 months)
Disease classification and medical treatments
Disease classification and medical treatments in the two randomization arms
Time frame: After completion of follow-up (12 months)
Patient satisfaction
Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score
Time frame: Immediately after initial diagnostic procedure
Costs
Expenditure on diagnostic procedures, treatment and loss of productivity
Time frame: After completion of follow-up (12 months)
Artificial intelligence
Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making
Time frame: Immediately after initial diagnostic procedure
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