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

NCT00245492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2009-01-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Chromocolonoscopy

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

Sponsors & Collaborators

  • American College of Gastroenterology

    collaborator OTHER

  • Stony Brook University

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Charles J Kahi, MD · Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00245492 on ClinicalTrials.gov