Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.