Comparative Effectiveness of Virtual and Optical Colonoscopy for Colorectal (CRC) Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 5
- 主要终点
- Compare the test characteristics (sensitivity, specificity, positive and negative predictive value) of Computed Tomography colonography (CT-C) in the post Colorectal cancer resection using optical colonoscopy as the reference standard
研究概览
简要总结
The goal of this study is to compare the findings of virtual (CT-colonography) with findings of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal cancer surveillance.
详细描述
The goal of this study is to compare, both clinically and from a cost-effectiveness perspective, virtual or CT-C (CT-Colonography) to standard CT scan and optical colonoscopy (OC). Virtual colonoscopy is a combination of a radiologic evaluation of the abdomen and pelvis with intra-colonic imaging. Previous research supports the concept that CT-C may be an effective substitute for the current OC and address limited compliance for surveillance for CRC survivors. Post-operative CRC surveillance strategies are effective, but depend upon patient compliance which is less than desired. Improved adherence is linked with greater cost-effectiveness as well as better clinical outcomes. CT-C possesses potential advantages: convenience as a single test, less risk, possibly patient preference and lower total costs. Costs would be reduced through direct (provision of fewer optical colonoscopies) and indirect means (reduction in time lost from work by patient and chaperone, etc.). When extrapolated across the roughly 200,000 OCs performed annually in the US for this indication reduced utilization of even 50% in a high unit cost procedure like OC would yield substantial savings without a reduction in clinical quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of CRC without clear evidence of metastatic disease who have completed their acute cancer-specific treatment
- •Patients aged 18 years or older
- •Patients who have signed an approved informed consent form
排除标准
- •Patients with a diverting ileostomy, with a history of inflammatory bowel disease, FAP, or active GI symptoms (gastrointestinal bleed, diarrhea, severe abdominal pain, etc.)
- •Patients who are pregnant
结局指标
主要结局
Compare the test characteristics (sensitivity, specificity, positive and negative predictive value) of Computed Tomography colonography (CT-C) in the post Colorectal cancer resection using optical colonoscopy as the reference standard
时间窗: One year post colorectal cancer resection
To evaluate the test characteristics (sensitivity, specificity, positive and negative predictive value) of CT colonography (CT-C) for detecting colorectal adenomas and cancers in the post-CRC resection surveillance setting, using optical colonoscopy (OC) as the reference standard.
次要结局
- Compare the costs and outcomes of Computed Tomography Colonography versus independent Optical Colonoscopy plus Computed Tomography for post Colorectal Cancer resection surveillance.(One year post colorectral cancer resection)
