Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

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

Sponsors

Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Source Azienda Ospedaliero-Universitaria Careggi
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.

Overall Status Completed
Start Date May 20, 2017
Completion Date December 20, 2018
Primary Completion Date December 15, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis 30 days
Secondary Outcome
Measure Time Frame
Management of patient 30 days
Time reduction 30 days
CT scan reduction 30 days
Enrollment 400
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Bedside Ultrasound

Description: Patients presenting to the Emergency Department with abdominal pain suspected of acute diverticulitis are evaluated with standard care by an Emergency Physician (tutor); at the time the tutor requests an imaging test performed by Radiologist (CT scan or US scan), he notifies another physicians skilled in bedside abdominal US (ultrasonographer), who evaluates the patient and performs the US scan. Ultrasonographer after completation of US and knowing blood samples results fills in a standardized form reporting the diagnostic hypotesis, the need for additional work-up (if deemed necessary), and the disposition of the patient. The standardized form completed by the ultrasonographer will be compared with the actual management of the patient.

Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Overall Official
Last Name Role Affiliation
Peiman Nazerian, MD Principal Investigator Emergency Departmet Azienda Ospedaliero Universitaria Careggi
Location
Facility:
Department of Emergency Medicine | Figline Valdarno, Firenze, Italy
Emergency Department Azienda Ospedaliera Universitaria Careggi | Firenze, Tuscany, 50134, Italy
Emergency Department ASST degli Spedali Civili di Brescia | Brescia, 25123, Italy
Emergency Department Nuovo Ospedale di Prato | Prato, 59100, Italy
Location Countries

Italy

Verification Date

May 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero-Universitaria Careggi

Investigator Full Name: Peiman Nazerian

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov