Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Conditions
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Colorectal Cancer, Colorectal Polyp

Intervention / Treatment
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* Device: Colon capsule endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Incomplete colonoscopy<br>Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation. | Device: Colon capsule endoscopy<br>* Endoscopy performed using PillCam2 camera capsule for oral ingestion<br>|
| Colonoscopy general anesthesia<br>Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia. | Device: Colon capsule endoscopy<br>* Endoscopy performed using PillCam2 camera capsule for oral ingestion<br>|
| Colonoscopy declined<br>Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out. | Device: Colon capsule endoscopy<br>* Endoscopy performed using PillCam2 camera capsule for oral ingestion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete mucosal visualization combining incomplete investigations | By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations. | 10 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon capsule endoscopy, ct colonography, colonoscopy, endoscopy