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Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03279588
Enrollment
400
Registered
2017-09-12
Start date
2017-05-20
Completion date
2018-12-20
Last updated
2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Acute Diverticulitis

Keywords

Ultrasound diagnosis, Abdominal Ultrasound, Emergency Department

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.

Interventions

DIAGNOSTIC_TESTBedside Ultrasound

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.

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis30 daysSensitivity, 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

MeasureTime frameDescription
Management of patient30 daysTo evaluate the reliability of the management proposed by the ultrasonographer on the basis of clinical, laboratoristic and ultrasonographic data.
Time reduction30 daysTo evaluate if the use of bedside abdominal US performed by Emergency Physicians can reduce the time needed for the diagnosis
CT scan reduction30 daysTo 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026