Adenoma, Colorectal Cancer
Conditions
Keywords
Camera Capsule Endoscopy, Colorectal cancer screening, Optical colonoscopy, Colorectal cancer
Brief summary
The investigatior believe that implementing camera capsule endoscopy as a filter test to colonoscopy will increase screening participation, increase the number of individuals with detected intermediate- high risk adenomas or cancer, reduce the colonoscopy demand and reduce the number of complications.
Detailed description
The Danish national colorectal cancer screening program includes all citizens aged 50-74 years, who are invited biennially to a fecal test for invisible blood in the stool. If the test is positive the citizen is invited for a colonoscopy. 90% of the test-positive undergo colonoscopy. The detected cancers are at a significant earlier stage and survival from screening detected cancer is higher. It is also expected that cancer incidence will drop due to removal of the advanced adenomas before they develop into cancer. Although initial results are positive, there is room for improvement. Additionally there are rare but serious complications to colonoscopy in the form of bleeding or bowel perforation. Through four years the investigators have tested the colon capsule endoscopy method, and find that the investigation is associated with significantly less discomfort and that the diagnostic ability to find polyps \> 1 cm is better than colonoscopy.
Interventions
Camera Capsule Endoscopy in screening
Sponsors
Study design
Intervention model description
The investigators will include 124.214 consecutive citizens from the Region of Southern Denmark when they are invited for screening. The participants will be randomized into two groups using an automated randomization tool provided by Odense Patient data Explorative Network (OPEN). The randomization will be based on Zelen's pre-randomization principle and will take place prior to citizens receiving the invitation. The individuals are randomized into 62.107 people allocated in the intervention group and 62.107 allocated in the control group.
Eligibility
Inclusion criteria
* Participation in the Danish colorectal screening program
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CCE detection rate of polyps compared to OC | Within 30 days | The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol. |
Countries
Denmark