The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal. The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy. The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
500
EC-assisted colonoscopy
Standard colonoscopy
University Medical Center Göttingen
Göttingen, Germany
HELIOS St. Marienberg Hospital Helmstedt
Helmstedt, Germany
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
Northeim, Germany
HELIOS Medical Center Siegburg, Department of Gastroenterology
Siegburg, Germany
adenoma detection rate
completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.
Time frame: 25 minutes
polyp detection rate
Time frame: 1 Week
number of LGIN and HGIN adenomas detected
LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
Time frame: one week
polyp distribution
Time frame: 25 minutes
procedure time
Time frame: 25 Minutes
withdrawal time
without intervention time due to polypectomy
Time frame: 10 Minutes
ileum intubation rate
Time frame: 10 minutes
total colonoscopy rate
Time frame: 25 minutes
adverse events
perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy
Time frame: 25 minutes
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