The influence of hyoscine N-butylbromide on colonoscopic polyp detection ratio - Hyoscine N-butylbromide and colonic polyp detectio
- Conditions
- MedDRA version: 12.1Level: LLTClassification code 10010007Term: ColonoscopyMedDRA version: 12.1Level: LLTClassification code 10010003Term: Colonic polypMedDRA version: 12.1Level: LLTClassification code 10010036Term: Colorectal carcinomaIt is investigated whether the administration of Buscopan will improve the detection, removal and harvesting of colonic polyps during colonoscopy.
- Registration Number
- EUCTR2010-023643-15-NL
- Lead Sponsor
- Deventer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Patiënt is routinely referred for colonoscopy by GP or specialist, and the correct indication as well possible contraindications for the procedure have been verified by a gastroenterologist, which is a standard procedure in the Deventer Hospital
2. Patiënt is able to understand and give informed consent
3. The age should be above 30.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnancy
2. Myasthenia Gravis
3. Exacerbation of inflammatory bowel disease
4. (Suspicion of) active diverticulitis
5. Expectation of an estimated probability of complete colonoscopy of less than 50%, e.g. by the presence of a stenosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether bowel relaxation, induced by administration of hyoscine N-butylbromide, improves the detection, removal and colllection of colonic polyps during colonoscopy;Secondary Objective: To investigate whether the detection, removal and collection of colonic polyps is influenced by the age, sex, the presence of colonic diverticula, the person who performs the colonoscopy, withdrawal time, and the preparation of the colon;Primary end point(s): Poly detection ratio: the percentage of colonoscopies with at least one colonic polyp as compared to the total number of colonoscopies
- Secondary Outcome Measures
Name Time Method