Short summary

Colon Capsule Endoscopy (CCE) is a promising new technology that may have the potential to complement existing diagnostic methods to screen people for colorectal cancer. Delivered correctly, it may reduce costs, increase utilization of medical services, reduce risks for patients and overall improve screening rates among the population.

We do 8000 colonoscopies per year on the Funen Island and about 10% of those are incomplete due to excessive pain, fixed colon loops and others causes. The current standard procedure is to refer the patient to the Department of Radiology for a CT-colonography

The aim of this study is to compare the performance of CCE and CT colonography in a prospective study of patients with previously incomplete colonoscopy.

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Rationale

Optical colonoscopy is the standard method for evaluating the colon. This technique allows evaluation of the entire colon in most patients. Full colonoscopy including examination of the cecum is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. After an incomplete optical colonoscopy, patients are required to undergo another test in order to exclude clinically relevant lesions to reduce the risk of proximal cancer which has been shown to increase by twofold when colonoscopy was incomplete.

Endoscopic and radiological options to complete the colon assessment have been available in the last decades. Multiple alternative endoscopic techniques - such as colonoscopy with thinner colonoscopes, gastroscopes and device-assisted enteroscopes have been described. However, none of them has been clearly standardized.

CT colonography (CTC is a relatively new imaging technique that was first described in 1994. In large randomized trials on symptomatic patients, CTC has been shown to be as equally effective as colonoscopy - for the detection of large colorectal polyps and already developed colorectal cancer.  

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Description of the cohort

Patients will be prepared for examination for colonoscopy using bowel preparation. In case of incomplete colonoscopy due excessive pain, fixed colon loops and others causes, they will be included into the proposed study. However, the bowel preparation for colonoscopy is not optimal for CCE, therefore a new appointment for CCE and CT colonography is made. Bowel preparation optimal for CCE will be used in this study.

One hundred patients with an incomplete colonoscopy will be offered to go through CCE the day before CT colonography and the patients will meet the next day in the Department of Radiology  at the Hospital of Nyborg or Svendborg (OUH) for the CT colonography. Standard CCE reports and CT colonography reports will be made blinded to each other. The number of low risk, medium risk, and high risk polyps and the number of cancers detected by the 2 methods will be compared and statistically analyzed.

Before entering the study the patients will be interviewed for the following exclusion criteria:

• Previous gastrointestinal surgery except for appendectomy
• Known inflammatory bowel disease including Crohn's disease and ulcerative colitis
• An ostomy
• Diabetes
• Symptoms on bowel obstruction
• Pacemakers
• Kidney diseases

If the patients suffer from one or more of those exclusion criteria, they will be excluded from the study and will not receive patient information. If they do not suffer from the exclusions criteria, they will be approved for the study and included into the study by one of the project responsible doctors

Data and biological material

Data are obtained from a combination of questionnaires and records completed by clinicians performing CT-scan alongside CCE film interpretations.

Collaborating researchers and departments

Department of Surgery, Odense University Hospital, Svendborg

• Profesoor Gunnar Baatrup
• Professor Niels Qvist
• Postdoc Morten Kobæk Larsen
• PhD-student Anne-Kirstine Dyrvig