Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT? - Full Text View

Sponsored by:	VA Caribbean Healthcare System
Information provided by:	VA Caribbean Healthcare System
ClinicalTrials.gov Identifier:	NCT00619814

Purpose

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.

Condition	Intervention
Colorectal Cancer	Procedure: Double-contrast Barium enema, colonoscopy

MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Single Blind (Investigator), Single Group Assignment, Safety/Efficacy Study
Official Title:	Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?

Further study details as provided by VA Caribbean Healthcare System:

Enrollment:	50
Study Start Date:	September 2003
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	( Doris Toro, MD )
Study ID Numbers:	00171
Study First Received:	February 8, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00619814 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by VA Caribbean Healthcare System:

Colon polyps
Fecal occult blood test
Double contrast barium enema
Colonoscopy

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Colonic Polyps
Gastrointestinal Neoplasms

Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009