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Completed

NCT Number: NCT03279588

Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Emergency Medicine, Figline Valdarno, Firenze, Italy

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedside Ultrasound

Diagnostic Test

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.

Primary outcomes

  1. 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

  1. Management of patient

    Time frame: 30 days

    To evaluate the reliability of the management proposed by the ultrasonographer on the basis of clinical, laboratoristic and ultrasonographic data.

  2. Time reduction

    Time frame: 30 days

    To evaluate if the use of bedside abdominal US performed by Emergency Physicians can reduce the time needed for the diagnosis

  3. CT scan reduction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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