Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

Completed

• Conditions: Acute Diverticulitis; Abdominal Pain

• Registration Number: NCT03279588
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2017-05-20
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-09
• Study First Posted: 2017-09-12
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-20
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis	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 Outcome Measures

Name	Time	Method
Management of patient	30 days	To evaluate the reliability of the management proposed by the ultrasonographer on the basis of clinical, laboratoristic and ultrasonographic data.
CT scan reduction	30 days	To evaluate if the use of bedside abdominal US performed by Emergency Physicians can raduce the number of CT scans performed in patients with suspected acute diverticulitis
Time reduction	30 days	To evaluate if the use of bedside abdominal US performed by Emergency Physicians can reduce the time needed for the diagnosis

Trial Locations

Locations (4)

Emergency Department Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Tuscany, Italy

Department of Emergency Medicine; 🇮🇹 Figline Valdarno, Firenze, Italy

Emergency Department ASST degli Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Emergency Department Nuovo Ospedale di Prato; 🇮🇹 Prato, Italy