The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds. The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer. This study is a randomized controlled trial with 900 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,178
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
colonoscopy is performed without endocuff.
Kirurgisk Afdeling
Herning, Central Jutland, Denmark
adenoma
number of adenomas found during colonoscopy
Time frame: 2 weeks
cecal intubation rate
is the cecum reached during the colonoscopy
Time frame: up to 2 hours
cecal intubation time
number of minutes from start procedure to cecum reached
Time frame: up to 2 hours
withdrawal time
number of minutes from cecum reached to end of the procedure, only if no polyps are found
Time frame: up to 60 minutes
adenoma size
size of adenomas detected
Time frame: up to 4 weeks
adenoma site
where in the bowel the adenoma was detected
Time frame: up to 4 weeks
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