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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Double-contrast Barium enema, colonoscopy

• Registration Number: NCT00619814
• Lead Sponsor: VA Caribbean Healthcare System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-02
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-20
• Last Update Submitted: 2008-02-20
• Study First Posted: 2008-02-21
• Last Update Posted: 2008-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort group	Double-contrast Barium enema, colonoscopy	Cohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening.