Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy (SOCRATEC)

Odense University Hospital

Status: Enrolling

Conditions: Colorectal Polyp; Colorectal Cancer

Treatments: Device: Colon capsule endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04307901

20/4408

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Chrohn's disease with symptoms of stenosis and/or pacemaker

Trial design

600 participants in 3 patient groups

Incomplete colonoscopy

Description:

Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.

Treatment:

Device: Colon capsule endoscopy

Colonoscopy general anesthesia

Description:

Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia.

Treatment:

Device: Colon capsule endoscopy

Colonoscopy declined

Description:

Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out.

Treatment:

Device: Colon capsule endoscopy