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临床试验/NCT03443011
NCT03443011已完成不适用

Diagnostics in Diverticulitis (DIDit)

Uppsala University2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2017年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
2
主要终点
Presence of diverticulitis on low dose CT and/or full dose CT

研究概览

简要总结

This study focuses on if low dose CT without intravenous contrast has a high enough specificity and sensitivity for acute diverticulitis that it can be used as the primary diagnostic method instead of a full dose CT with intravenous contrast which is the standard method in Sweden.

详细描述

Patients will be recruited from the emergency departments in Mora and Vastmanland hospitals. All patients over the age of 50 with clinically suspected acute diverticulitis that meet inclusions criterium will be asked for participation. A Clinical examination and blood samples will be drawn.

Subjects will be sent to the radiology department where they will undergo computed tomography (CT) of the abdomen. The CT protocol consists of a low dose non contrast enhanced CT followed by a normal dose CT with intravenous contrast. This is needed as randomization of patients is not possible due to the fact that the Clinical diagnosis of diverticulitis is difficult and unreliable. This would lead to the situation that we would not know if a participant in the low dose CT Group has diverticulitis which was not seen with the low dose protocol or if the patient did not have diverticulitis.

The radiologist on call will examine the full dose CT examination and write a report as routine. At a later date Three blinded radiologists will examine first all low dose CT examinations and grade them according to our CT protocol. At a later date the radiologists will evaluate all full dose CT examinations using the same CT protocol.

Findings will then be compared between the two different CT methods and sensitivity and specificity for low dose CT will be calculated.

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
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over the age of 50
  • Clinically suspected acute diverticulitis
  • Low abdominal pain
  • WBC over 10 x 109/L or raised C-reactive protein levels 25 mg/L

排除标准

  • Pregnancy
  • Previous allergy to intravenous contrast
  • Renal failure or other reasons that the patient cannot undergo CT with iv contrast
  • Unable to give informed consent
  • Language barrier

研究组 & 干预措施

participants

Experimental

All participants will be examined with both CT techniques. First a low dose CT without intravenous contrast followed by the standard method, a full dose CT with intravenous contrast

干预措施: Low dose CT without intravenous contrast (Radiation)

结局指标

主要结局

Presence of diverticulitis on low dose CT and/or full dose CT

时间窗: Baseline

Colonic wall thickening \>5mm, pericolic fat stranding and diverticula on CT

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arnar Thorisson

Consulting radiologist

Uppsala University

研究点 (2)

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