Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
Recruiting now
Conditions studied: Colorectal Cancer, Colorectal Polyp
In brief
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps \>9 mm and polyps \>5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete. Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
Key facts
- Study ID
- NCT04307901
- Run by
- Odense University Hospital
- People needed
- 600
- Starts
- 2020-05-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2020-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.
You may not qualify if…
- Chrohn's disease with symptoms of stenosis and/or pacemaker
Where it is running
- Odense University Hospital — Svendborg, Denmark (enrolling)
Full record on ClinicalTrials.gov
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