Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?

University Hospital Muenster

Status: Unknown

Conditions: Colonic Polyp; Colonic Neoplasms; Colonoscopy; Colonic Adenoma

Treatments: Device: Endorings-2

Study type: Interventional

Funder types: Other

Identifiers

NCT03385434

2017-635-f-S

Details and patient eligibility

About

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).

Enrollment: 292 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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292 participants in 2 patient groups

Endorings-assisted screening colonoscopy

Experimental group

Description:

146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.

Treatment:

Device: Endorings-2

Standard screening colonoscopy

No Intervention group

Description:

146 patients with an indication for screening endoscopy will receive a standard colonoscopy.