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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Double-contrast Barium enema, colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

Collaborators and Investigators

• Sponsor: VA Caribbean Healthcare System

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): October 1, 2005
• Study Completion (ACTUAL): October 1, 2005

Study Registration Dates

• First Submitted: February 8, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (ESTIMATE): February 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 21, 2008
• Last Update Submitted That Met QC Criteria: February 20, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Colonoscopy; Fecal occult blood test; Colon polyps; Double contrast barium enema
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 00171