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

VA Caribbean Healthcare System

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: Double-contrast Barium enema, colonoscopy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00619814

00171

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asymptomatic patients older than 50 years of age, with at least one positive FOBT
• Without history of colon cancer and/or polyps
• Gross gastrointestinal bleeding or prior colonoscopy or DCBE
• Who were willing to participate in the study
• Were included in the investigation.

Exclusion criteria

• Patients with poor cardio-respiratory condition
• Coagulation deficiency, use of anticoagulants or other drugs affecting coagulation
• Severe renal or liver disease
• Hospitalized patients and palpable abdominal or rectal mass were excluded from the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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50 participants in 1 patient group

Cohort group

Other group

Description:

Cohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening.

Treatment:

Procedure: Double-contrast Barium enema, colonoscopy