Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis
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|ClinicalTrials.gov Identifier: NCT03279588|
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : January 1, 2019
|Condition or disease||Intervention/treatment|
|Acute Diverticulitis Abdominal Pain||Diagnostic Test: Bedside Ultrasound|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Diagnostic Accuracy and Role of Bedside Ultrasound in Patients With Suspected Acute Diverticulitis|
|Actual Study Start Date :||May 20, 2017|
|Actual Primary Completion Date :||December 15, 2018|
|Actual Study Completion Date :||December 20, 2018|
- Diagnostic Test: Bedside 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.
- 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.
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279588
|Emergency Department Azienda Ospedaliera Universitaria Careggi|
|Firenze, Tuscany, Italy, 50134|
|Emergency department, Ospedale Maggiore di Bologna|
|Emergency Department ASST degli Spedali Civili di Brescia|
|Brescia, Italy, 25123|
|Emergency Department ASST Grande Ospedale Metropolitano Niguarda|
|Miano, Italy, 20162|
|Emergency Department Nuovo Ospedale di Prato|
|Prato, Italy, 59100|
|Principal Investigator:||Peiman Nazerian, MD||Emergency Departmet Azienda Ospedaliero Universitaria Careggi|