Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Condition(s) studied

Investigational drug(s) / intervention(s)

Colon capsule endoscopy: Endoscopy performed using PillCam2 camera capsule for oral ingestion

Study summary

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

Primary outcome measure(s)

• Complete mucosal visualization combining incomplete investigations — 10 years
  By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.

Trial sites (1)

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