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Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

RecruitingNAAges 18 Years - anyAllOdense University Hospital
NCT06475560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system

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📋 Eligibility rules (as published)
Inclusion Criteria: * Older than 18 years * Symptomatic patient referred for colonoscopy assessment * Able to provide oral and written informed consent Exclusion criteria 1. Require hospital admission for inpatient colonoscopy 2. Previous OC with poor bowel preparation within the last 5 years 3. Patient is unable to provide oral and written informed consent 4. History of stenosis of the digestive tract 5. Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma\* 6. Patient has a pacemaker/defibrillator 7. Patient is pregnant or breastfeeding 8. Known allergies to the bowel preparation regimen 9. Have severe kidney disease 10. Known chronic constipation 11. Imaging examination suggestive for a colorectal tumour 12. Anamnestic suspicion of microscopic colitis, where biopsy is needed \*including Whipple
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What it tests

  • CCE arm
  • CC arm
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Where

1 site
Odense University Hospital
Odense C, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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