Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 792
- Locations
- 4
- Primary Endpoint
- Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Study Overview
Brief Summary
The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients undergoing screening colonoscopy
Exclusion Criteria
- •Age < 50
- •Prior colon resection
- •Inflammatory bowel disease
- •Prior colonoscopy or sigmoidoscopy
- •More than one first-degree relative with colon cancer
Outcomes
Primary Outcomes
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Time Frame: Cross-sectional prevalence of adenomas between the 2 study groups
Secondary Outcomes
No secondary outcomes reported