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Clinical Trials/NCT03279588
NCT03279588
Completed
Not Applicable

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

Azienda Ospedaliero-Universitaria Careggi4 sites in 1 country400 target enrollmentMay 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Diverticulitis
Sponsor
Azienda Ospedaliero-Universitaria Careggi
Enrollment
400
Locations
4
Primary Endpoint
Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2017
End Date
December 20, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peiman Nazerian

Principal Investigator

Azienda Ospedaliero-Universitaria Careggi

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (4)

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