To investigate whether bowel relaxation, induced by administration of hyoscine N-butylbromide, improves the detection, removal and colllection of lcolonic polyps during colonoscopy
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Poly detection ratio: the percentage of colonoscopies with at least one
colonic polyp as compared to the total number of colonoscopies.
(Ref: colonoscopic Withdrawal Times and Adenoma Detection during Screening
Colonoscopy. Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. NEJM
2006;355 2533-2541)
Secondary outcome
1 The total number of polyps seen during colonoscopy, divided by the total
number of colonoscopies
2. The total number of polyps removed during colonoscopy, divided by the total
number of colonoscopies
3. The total number of polyps retrieved for pathological investigation, diverd
by the total number of colonoscopie
These parameters wille be expressed in a percentage and will be determined for
polyps with a stalk and for flat polyps, acoording to their resepctive sizes (
(< 5 mm, 5-10 mm, > 10 mm).
(Ref: Colonoscopic Withdrawal Times and Adenoma Detection during Screening
Colonoscopy. Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. NEJM
2006; 355:: 2533-2541)
Background summary
Colorectal carcinoma is an important problem and cause of death. A large
proportion of cases can be prevented by the removal of the precursor lesions
which is a colonic polyp. This is done via a colonoscopy, alowing for visual
detection, removal and harvesting of polyps.
The problem is, that during colonoscopy up to 10% of polyps can be missed.
Also, some patients present with colorectal cancer despite a negative
colonoscopy in the preceding three years. It is generally assumed that these
tumours have arosen from missed polyps.
This has instigated a lot of research on methods to improve polyp detection
during colonoscopy.
The problem is that the colon is no smooth tube but has a lot of folds and
bends. Some polyps may be hidden behind these folds.
Folds are caused by contractions of the circulair muscle layer of the bowel.
There are indications that relaxation of the muscular layer will decrease the
folds, and therefor may facilitate visual inspection. Currently, there is only
one underpowered study inidicating that this indeed may be the case (p=0,06)
Polyps should not only be removed but also collected for pathology. This may be
hampered by active persitalsis. It is unknown whether relaxation of the bowel
will facilitate the collection of polyps.
Study objective
To investigate whether bowel relaxation, induced by administration of hyoscine
N-butylbromide, improves the detection, removal and colllection of lcolonic
polyps during colonoscopy
Study design
prospective randomized placebo-controlled trial, double-blind
Study burden and risks
Participation bears burden nor risk. Participation is of unclear benefit
Nico Bolkesteinlaan 75
7416 SE Deventer
NL
Nico Bolkesteinlaan 75
7416 SE Deventer
NL
Listed location countries
Age
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.
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023643-15-NL |
| ISRCTN | ISRCTN25405865 |
| CCMO | NL34514.075.10 |