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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
VA Caribbean Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 8, 2008
    Last Updated
    February 20, 2008
    Sponsor
    VA Caribbean Healthcare System
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    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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