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

NCT00619814 | Completed DMC

• 1 other identifier: 00171
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

Colon polyps; Fecal occult blood test; Double contrast barium enema; Colonoscopy

Study Arms (1)

Cohort group

OTHER

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

Interventions

Double-contrast Barium enema, colonoscopy PROCEDURE

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.

Cohort group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Caribbean Healthcare System: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: September 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 21, 2008

Record last verified: 2008-02