Patients with positive FOBT harbour a risk of colorectal cancer of about 5% and of advanced adenomas of about 40% Cancer Malignant neoplasm of colon and rectum
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All consecutive patients aged 55-64 years, either sex, referred to the Endoscopic Units of Torino and Novara for screening colonoscopy due to positive fecal occult blood test (FOBT)
Exclusion criteria
Exclusion criteria: 1. Use of antiplatelet agents or anticoagulants that preclude removal of polyps 2. Refusal to participate or inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the use of NBI might increase the detection rate of advanced adenomas compared with High Definition White Light colonoscopy (HD-WL); so, the primary outcome measures will be the overall number of advanced adenomas detected in both groups and the number of advanced adenomas per patient. The definition of advanced adenoma includes all adenomas with a diameter = 1 cm and/or villous component of at least 25%, and/or high-grade dysplasia. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the ADR, defined as the percentage of patients with =1 adenomas, and the total number of adenomas. So, the secondary outcome measures will be the overall number of patients with at least one adenoma in both groups and total number of adenomas found in the patients according to their group. | — |
Countries
Italy