Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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 while ensuring fewer findings are missed.

One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy.

Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.

Eligibility criteria

Qualifiers

Older than 18 years

Symptomatic patient referred for colonoscopy assessment

Able to provide oral and written informed consent

Disqualifiers

Require hospital admission for inpatient colonoscopy

Previous OC with poor bowel preparation within the last 5 years

Patient is unable to provide oral and written informed consent

History of stenosis of the digestive tract

Trial design

Treatments tested in this trial

  • CCE arm
  • CC arm

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Region Syddanmark

Collaborator