Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)
The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
561
Olympus Disposable distal attachment 15mm diameter, 4mm depth
University of Muenster
Münster, North Rhine-Westphalia, Germany
University Medical Center Göttingen
Göttingen, Germany
HELIOS St. Marienberg Klinik Helmstedt
Helmstedt, Germany
HELIOS Albert-Schweitzer-Klinik
Northeim, Germany
Adenoma detection rate
Proportion of patients having at least one adenoma
Time frame: 1 year
Polyp detection rate
Proportion of patients having at least one adenoma
Time frame: 1 year
Bowel preparation result
Time frame: one day
Coecum intubation rate
Time frame: one year
Ileum intubation rate
Time frame: one year
Coecum intubation time
Time frame: one day
withdrawal time
Time frame: one day
mucosal laceration
Time frame: one day
severe bleeding
Time frame: one day
perforation
Time frame: one day
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HELIOS Medical Center Siegburg
Siegburg, Germany
Wroclaw Medical University
Wroclaw, Poland