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Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?

NCT00619814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-02-21

No results posted yet for this study

Summary

The research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE), a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation of patients with positive fecal occult blood as compared to colonoscopy, which is considered the best evaluation method. Colonoscopy involves the direct visualization of the colon using a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in this protocol.

Additional aims of this study are: to determine the localization, number, size and pathologic characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the patient preference between both studies.

This study is limited to those patients 50 years or older who are at average risk for colon cancer and who had a positive fecal occult blood screening test.

Conditions

Interventions

PROCEDURE

Double-contrast Barium enema, colonoscopy

This is a blinded cohort study comparing double contrast barium enema (DCBE) and colonoscopy in detecting polyps and/or cancer in patients with positive FOBT. Initial evaluation consisted of complete clinical history and physical examination. A DCBE and a colonoscopy were performed in all patients. All polyps identified during colonoscopy were removed and classified by histology. Sensitivity and specificity of DCBE for polyp and/or cancer detection was determined. Tolerability and grade of satisfaction with study procedures was assessed.

Sponsors & Collaborators

  • VA Caribbean Healthcare System

    lead FED

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2005-10-31
Completion
2005-10-31

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Diseases

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 NCT00619814 on ClinicalTrials.gov