Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
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:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.|
- Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. [ Time Frame: Cross-sectional prevalence of adenomas between the 2 study groups ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245492
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Roudebush VA Medical Center|
|Indianapolis, Indiana, United States|
|United States, New York|
|SUNY Stony Brook|
|Stony Brook, New York, United States|
|Principal Investigator:||Charles J Kahi, MD||Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana|