Adenoma, Cancer, Polyp
Conditions
Keywords
colon cancer, adenoma, colon polyps
Brief summary
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.
Interventions
EC-assisted colonoscopy
DEVICEStandard colonoscopy
Standard colonoscopy
Sponsors
Helios Albert-Schweitzer-Klinik Northeim
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent
Exclusion criteria
* pregnancy * age\<18 years * known colonic strictures * chronic inflammatory bowel disease * active inflammation * s/p colonic resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate | 25 minutes | completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of LGIN and HGIN adenomas detected | one week | LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia |
| polyp distribution | 25 minutes | — |
| procedure time | 25 Minutes | — |
| polyp detection rate | 1 Week | — |
| ileum intubation rate | 10 minutes | — |
| total colonoscopy rate | 25 minutes | — |
| adverse events | 25 minutes | perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy |
| withdrawal time | 10 Minutes | without intervention time due to polypectomy |
Countries
Germany
Outcome results
None listed