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NCT00245492 Clinical Trial

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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00245492
Other study ID # 0508-64
Secondary ID 2005ACG-100CRC
Status Completed
Phase N/A
First received October 26, 2005
Last updated January 27, 2009
Start date May 2006
Est. completion date December 2008

Study information
Verified date January 2009
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 792
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Indiana University Indianapolis Indiana
United States Roudebush VA Medical Center Indianapolis Indiana
United States SUNY Stony Brook Stony Brook New York

Sponsors (4)
Lead Sponsor Collaborator
Indiana University American College of Gastroenterology, Stony Brook University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. Cross-sectional prevalence of adenomas between the 2 study groups No
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