Clinical trial NCT03279588: Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis
Official title: Diagnostic Accuracy and Role of Bedside Ultrasound in Patients With Suspected Acute Diverticulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Diverticulitis
Abdominal Pain
Keywords: Ultrasound diagnosis
Abdominal Ultrasound
Emergency Department
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every patient presenting with symptoms suspected of diverticular disease to the Emergency Department of four Italian hospitals will be considered eligible for the study

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.

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

Primary outcomes:
measure: Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis
timeFrame: 30 days
Secondary outcomes:
measure: Management of patient
timeFrame: 30 days
measure: Time reduction
timeFrame: 30 days
measure: CT scan reduction
timeFrame: 30 days
Other outcomes:
Locations:
city: Figline Valdarno
country: Italy
facility: Department of Emergency Medicine
state: Firenze
city: Firenze
country: Italy
facility: Emergency Department Azienda Ospedaliera Universitaria Careggi
state: Tuscany
city: Brescia
country: Italy
facility: Emergency Department ASST degli Spedali Civili di Brescia
city: Prato
country: Italy
facility: Emergency Department Nuovo Ospedale di Prato
Study officials:
affiliation: Emergency Departmet Azienda Ospedaliero Universitaria Careggi
name: Peiman Nazerian, MD
role: PRINCIPAL_INVESTIGATOR
References:
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