RecruitingNCT04307901

Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy


Sponsor

Odense University Hospital

Enrollment

600 participants

Start Date

May 1, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a pill-sized camera (colon capsule endoscopy) can safely examine the colon in patients who could not complete or refused a standard colonoscopy. This could offer a less invasive alternative for colorectal cancer screening. **You may be eligible if...** - You had an incomplete colonoscopy (the scope could not reach all areas) - You were referred for a colonoscopy under general anesthesia - You completed the bowel preparation but declined to go ahead with the standard colonoscopy **You may NOT be eligible if...** - You have Crohn's disease with symptoms suggesting a bowel narrowing (stricture) - You have a pacemaker (which may interfere with the capsule's wireless signal) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEColon capsule endoscopy

Endoscopy performed using PillCam2 camera capsule for oral ingestion


Locations(1)

Odense University Hospital

Svendborg, Denmark

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NCT04307901


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