COLON CANCER SCREENING BY MEANS OF COLON CAPSULE ENDOSCOPY - A pilot study
- Conditions
- adenomascolorectal polyps/bowel cancer10017990
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
All consecutive ambulatory patients referred for a colonoscopy at the Gastroenterology and Hepatology Department of the Erasmus MC because of a suspicion of colorectal polyps or colorectal cancer or a positive iFOBT after participation in a FOBT-based CRC screening trial will be eligible for participation.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability or refusal to provide informed consent.
- Persons with a severe or terminal disease with a life-expectancy of less than 5 years.
- An allergy or any other known contraindication to the medication used in the study, including:
- Renal failure, eGFR <60 ml/min/1.73m2
- Congestive heart failure NYHA class III or IV.
- Dysphagia or other swallowing disorder which makes it impossible to swallow the capsule.
- Personal history of gastrointestinal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Cardiac pacemakers or other implanted electro-medical equipment.
- An MRI scheduled within 14 days after ingestion of the capsule.
- Although pregnancy is not likely in this cohort, pregnant women are also excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The pilot study will focus completely on testing of the quality of the CCE<br /><br>procedure as intended in the screening trial. The main study parameters are<br /><br>feasibility and logistical shortcomings, efficacy of bowel preparation and<br /><br>understandability of information material. </p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>