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

Colorectal Cancer Clinical Trial

— DCBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619814
• Other study ID #: 00171
• Status: Completed
• Phase: N/A
• First received: February 8, 2008
• Last updated: February 20, 2008
• Start date: September 2003
• Est. completion date: October 2005

Study information

• Verified date: February 2008
• Source: VA Caribbean Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Caribbean Healthcare System