About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.
Disqualifiers
Chrohn's disease with symptoms of stenosis and/or pacemaker
Trial population
All adults referred to colon capsule endoscopy from the surgical department of Odense University Hospital, which signs consent form enabling us to retrieve personal data.
Trial design
Cohort
Prospective
Treatments tested in this trial
Colon capsule endoscopy
DeviceEndoscopy performed using PillCam2 camera capsule for oral ingestion
Treatment groups
Trial outcomes
Primary outcomes
Complete mucosal visualization combining incomplete investigations
By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.
Secondary outcomes
Completion rate of colon capsule endoscopy
Total and subgroup completion rates of investigations
Safety of colon capsule endoscopy
Total and subgroup safety of investigations
Quality of colon capsule endoscopy
Sensitivity and specificity compared to colonoscopies
Economic evaluation
Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.
Sponsors and contacts
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