Clinical trial · Interventional
Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Double-contrast Barium enema, colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cohort group
- description
- Cohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening.
- interventionNames
- Procedure: Double-contrast Barium enema, colonoscopy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available