Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Svendborg
Contact Information
Primary
Gunnar Baatrup, Prof.
gunnar.baatrup@rsyd.dk
+4520575154
Time Frame
Start Date: 2020-05-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 600
Treatments
Incomplete colonoscopy
Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.
Colonoscopy general anesthesia
Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia.
Colonoscopy declined
Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov