Which bowel preparation regime gives the most optimal Colon Capsule Endocscopy in patients with high risk polyps.
- Conditions
- Endoscopic examination of the colon and rectum for polyps and cancersMedDRA version: 19.0Level: LLTClassification code 10010026Term: Colorectal cancer Duke's ASystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10010027Term: Colorectal cancer Duke's CSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10010028Term: Colorectal cancer Duke's DSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10010029Term: Colorectal cancer NOSSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10010024Term: Colorectal cancer Duke's B1System Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10010025Term: Colorectal cancer Duke's B2System Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10010031Term: Colorectal cancer stage B2System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002237-30-DK
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
Patients in high risk of delopment of polyps in the colon or rectum because of previously presence of polyps larger than 10 mm and/or more than 3 polyps in one patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
Criteria for exclusion are:
- Hypersensitivity to the active substances or one or more of the subsidiary substances, including
o Phenylketonuri (due to aspartam in Moviprep®)
o Glucose-6-phosphate-dehydrogenase deficiency (due to ascorbate in Moviprep®)
- Gastrointestinal obstruction or perforation
- Previous problems with bowel cleansing
- Ileus
- Toxic megacolon, which complicates serious inflammatoric conditions in the intestinal canal including Morbus Crohn and colitis ulcerosa
- Serious (known) kidney disease
- Previous surgery/resection of colon or rectum (except for appendectomy)
- Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method