Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Recruiting

• Conditions: Colorectal Cancer; Colorectal Polyp
• Interventions: Device: Colon capsule endoscopy

• Registration Number: NCT04307901
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Status Verified: 2020-05
• Study Start: 2020-05-01
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20
• Primary Completion: 2030-10-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incomplete colonoscopy	Colon capsule endoscopy	Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.
Colonoscopy general anesthesia	Colon capsule endoscopy	Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia.
Colonoscopy declined	Colon capsule endoscopy	Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Completion rate of colon capsule endoscopy	2 years	Total and subgroup completion rates of investigations
Economic evaluation	1 year	Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.
Safety of colon capsule endoscopy	1 year	Total and subgroup safety of investigations
Quality of colon capsule endoscopy	1 year	Sensitivity and specificity compared to colonoscopies
Patient preference	2 years	Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Svendborg, Denmark