Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 891
- 试验地点
- 2
- 主要终点
- Negative Appendectomy
研究概览
简要总结
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.
详细描述
Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern.
The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected of having acute appendicitis
- •Referred for abdomen CT from Emergency Department
排除标准
- •Body mass index < 18.5 kg/m2 (ultrasonography is favored)
- •Intravenous contrast-enhancement is contraindicated
结局指标
主要结局
Negative Appendectomy
时间窗: 1 week after surgery
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
次要结局
- Additional Imaging Test(s)(1 week after CT)
- Appendiceal Perforation(1 week after surgery)
- Interval Between CT and Appendectomy(1 day after surgery)
- Interval Between CT and Discharge Without Surgery(3 months after CT)
- Interval From CT to Discharge After Appendectomy(3 months after CT)
- Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis(3 months after CT)
- Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis(3 months after CT)
- Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.(3 months after CT)
- Visualization of the Normal Appendix(3 months after CT)
研究者
Kyoung Ho Lee
Dr.
Seoul National University Bundang Hospital