Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

Summary

The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed.

One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy.

Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.

Conditions

• Colorectal Cancer

Interventions

DIAGNOSTIC_TEST

CCE arm

Twice a week, patients will attend the in-hospital clinic in groups of four persons. They will bring their completed FIT sample, questionnaire, and the signed consent form. A project nurse will administer the capsules in the morning, and the patients can leave after. When the capsule investigation is completed, patients must return their belt and receiver to the Department of Surgery, OUH. After a few days, the patient will receive an electronic letter with the results and information regarding upcoming steps. Those with positive findings or an incomplete investigation will be given a new appointment according to the current clinical routine. A second questionnaire will be sent to the patient 2 weeks after the completed procedure.

DIAGNOSTIC_TEST

CC arm

Patients will start bowel cleansing according to the instructions. They will bring their completed questionnaire and the signed consent form to the scheduled colonoscopy. They will continue to follow the routine clinical setup for outpatient colonoscopy and will only receive, by digital post, after 2 weeks from the procedure, an extra second questionnaire.

Sponsors & Collaborators

• Region Syddanmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Anastasios Koulaouzidis, Professor · OUH og Svendborg Sygehus

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-27

Primary Completion

2026-08-01

Completion

2026-08-31

Countries

• Denmark

Study Locations