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Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245492
Enrollment
792
Registered
2005-10-28
Start date
2006-05-31
Completion date
2008-12-31
Last updated
2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma, Colon Cancer, Polyp

Keywords

Colonoscopy, Chromoscopy, Prevention

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.

Interventions

PROCEDUREChromocolonoscopy

Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Sponsors

American College of Gastroenterology
CollaboratorOTHER
Stony Brook University
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.Cross-sectional prevalence of adenomas between the 2 study groups

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026