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

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Double-contrast Barium enema, colonoscopy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort group<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon polyps, Fecal occult blood test, Double contrast barium enema, Colonoscopy