跳至主要内容
临床试验/NCT03279588
NCT03279588已完成不适用

Diagnostic Accuracy and Role of Bedside Ultrasound in Patients With Suspected Acute Diverticulitis

Azienda Ospedaliero-Universitaria Careggi4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
4
主要终点
Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis

研究概览

简要总结

Colonic diverticulitis is a common clinical condition in patients presenting to the Emergency Department (ED) with abdominal pain. The diagnosis and staging of patients with suspected acute diverticulitis is often made by CT imaging with intravenous contrast, which involves radiation exposure, is expensive and has contraindications. The aim of this study is to evaluate the diagnostic accuracy and role of bedside abdominal US for the diagnosis of acute diverticulitis

详细描述

Colonic diverticulitis is a common clinical condition; about 20% of patients with colonic diverticulosis experience abdominal symptoms and, eventually, complications such as episodes of diverticulitis or bleeding. The distinction between patients with uncomplicated or complicated diverticulitis affects the clinical management: medical therapy for the first, interventional therapy for the latter. CT imaging with intravenous contrast has become the gold standard in the diagnosis and staging of patients with suspected acute diverticulitis but, unfortunately, CT involves radiation exposure, is expensive and has contraindications. UltraSound (US) is a real-time dynamic examination with wide availability and easy accessibility and may be useful in diagnosing and managing critically ill patients who cannot be moved to CT. In a recent meta-analysis, US exam performed by Radiologists showed a pooled sensitivity of 90% (vs 95% for CT, p = 0.86) and a specificity of 90% (vs 96% for CT, p = 0.04). US is increasingly used at bedside to rapidly assess patients presenting to the Emergency Department. No previous studies have investigated the diagnostic accuracy of abdominal US performed by physician at bedside as an extension of physical examination. This study evaluates the diagnostic accuracy of bedside abdominal US.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • informed consent obtained
  • patients with abdominal pain presenting to the Emergency Department with a suspicon of diverticular disease, in whom the tutor physician orders an imaging study (abdominal CT or abdominal US performed by the Radiologist)

排除标准

  • no ultrasonographer physician who can perform bedside abdominal US is present
  • the patient does not undergo imaging study
  • clinical conditions of the patient are particularly severe, preventing an adequate enrollment

结局指标

主要结局

Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis

时间窗: 30 days

Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of bedside abdominal US performed by Emergency Physicians for the diagnosis of acute diverticulitis.

次要结局

  • Management of patient(30 days)
  • CT scan reduction(30 days)
  • Time reduction(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peiman Nazerian

Principal Investigator

Azienda Ospedaliero-Universitaria Careggi

研究点 (4)

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