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

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Indiana University

Status

Completed

Conditions

Colon Cancer
Polyp
Adenoma

Treatments

Procedure: Chromocolonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00245492
2005ACG-100CRC
0508-64

Details and patient eligibility

About

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.

Enrollment

792 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

792 participants in 1 patient group

1
Experimental group
Description:
Chromocolonoscopy
Treatment:
Procedure: Chromocolonoscopy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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