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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: Colonoscopy
MedDRA version: 12.1Level: LLTClassification code 10010003Term: Colonic polyp
MedDRA version: 12.1Level: LLTClassification code 10010036Term: Colorectal carcinoma
It 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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