Colonic Adenoma, Colonic Neoplasms, Colonic Polyp, Colonoscopy
Conditions
Keywords
Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy
Brief summary
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate). Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal. This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).
Interventions
DEVICEEndorings-2
292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
Sponsors
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with an indication for a screening colonoscopy.
Exclusion criteria
* Patients under 18 years, pregnancy * Patients with prior colectomy or partial colectomy * Patients with a history of colorectal cancer * Patients with hereditary polyposis syndromes (FAP, HNPCC) * Patients with a stricture of the colon * Patients receiving anticoagulation prohibiting a colonoscopy * inability to have a patient education * bad conditions prohibiting a colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the adenoma detection rate during screening colonoscopy | Intraoperative. Adenomas detected directly during the examination. | The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy. |
Countries
Germany
Contacts
Primary ContactFrank Lenze, MD
Backup ContactArne Bokemeyer, MD
Outcome results
None listed