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

This study has been completed.
Sponsor:
Collaborators:
American College of Gastroenterology
Stony Brook University
University of Chicago
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00245492
First received: October 26, 2005
Last updated: January 27, 2009
Last verified: January 2009

October 26, 2005
January 27, 2009
May 2006
December 2008   (final data collection date for primary outcome measure)
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 ]
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Complete list of historical versions of study NCT00245492 on ClinicalTrials.gov Archive Site
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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.

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Colon Cancer
  • Polyp
  • Adenoma
Procedure: Chromocolonoscopy
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
Experimental: 1
Chromocolonoscopy
Intervention: Procedure: Chromocolonoscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
792
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245492
0508-64, 2005ACG-100CRC
Not Provided
Charles Kahi, MD, Indiana University
Indiana University
  • American College of Gastroenterology
  • Stony Brook University
  • University of Chicago
Principal Investigator: Charles J Kahi, MD Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
Indiana University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP