Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
研究概览
简要总结
Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.
Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.
Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
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
- Double (Participant, Investigator)
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
- •acute right side abdominal pain
- •willing participate study
排除标准
- •acute disease
- •malignancy
- •other disease which might cause discomfort
结局指标
主要结局
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
时间窗: within the first week of complaints
次要结局
- Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.(one year)