Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02826993 |
| Other study ID # |
OdenseUH_MKL1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2016 |
| Est. completion date |
September 2019 |
Study information
| Verified date |
August 2018 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5%
and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons.
The current standard procedure is to refer the patient to the department of radiology for a
CT-colonography. In some instances the radiology department can offer the investigation the
next day, and thus in the same colon preparation. At other times they cannot, and the patient
has to go through an second colon preparation for the colonography.
A CCE procedure could be provided to the participants immediately after the failed
colonoscopy and the investigation can be completed the next morning in the same bowel
preparation without a visit to the radiology department.
Description:
Optical colonoscopy is the standard method for evaluating the colon. This technique allows
evaluation of the entire colon in most patients. Full colonoscopy including examination of
the cecum is associated with an increased detection rate of advanced neoplasia, as 33-50% of
advanced neoplasia is located in the proximal colon. After an incomplete optical colonoscopy,
participants are required to undergo another test in order to exclude clinically relevant
lesions to reduce the risk of proximal cancer which has been shown to increase by twofold
when colonoscopy was incomplete.
Endoscopic and radiological options to complete the colon assessment have been available in
the last decades. Multiple alternative endoscopic techniques-such as colonoscopy with thinner
colonoscopes, gastroscopes and device-assisted enteroscopes have been described. However,
none of them has been clearly standardized.
CT colonography (CTC), is a relatively new imaging technique that was first described in
1994. In large randomized trials on symptomatic patients, CTC has been shown to be as equally
effective as colonoscopy - for the detection of large colorectal polyps and already developed
colorectal cancer.
Colon Capsule Endoscopy (CCE) is a promising new technology that may have the potential to
complement existing diagnostic methods to screen people for colorectal cancer. Delivered
correctly, it may reduce costs, increase utilization of medical services, reduce risks for
patients and overall improve screening rates among the population.
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island and about
10% of those are incomplete due to excessive pain, fixed colon loops, and others causes. The
current standard procedure is to refer the participant to the Department of Radiology for a
CT-colonography.
