Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT? (DCBE)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double-contrast Barium enema, colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colon polyps, Fecal occult blood test, Double contrast barium enema, Colonoscopy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cohort group
Arm Description
Cohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00619814
First Posted
February 8, 2008
Last Updated
February 20, 2008
Sponsor
VA Caribbean Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00619814
Brief Title
Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
Acronym
DCBE
Official Title
Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VA Caribbean Healthcare System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colon polyps, Fecal occult blood test, Double contrast barium enema, Colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort group
Arm Type
Other
Arm Description
Cohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening.
Intervention Type
Procedure
Intervention Name(s)
Double-contrast Barium enema, colonoscopy
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
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Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
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