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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 : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Peiman Nazerian, 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

Condition or disease Intervention/treatment
Acute Diverticulitis Abdominal Pain Diagnostic Test: Bedside Ultrasound

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.

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Every patient presenting with symptoms suspected of diverticular disease to the Emergency Department of four Italian hospitals will be considered eligible for the study
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

Information from the National Library of Medicine

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


Locations
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Italy
Department of Emergency Medicine
Figline Valdarno, Firenze, Italy
Emergency Department Azienda Ospedaliera Universitaria Careggi
Firenze, Tuscany, Italy, 50134
Emergency Department ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Emergency Department Nuovo Ospedale di Prato
Prato, Italy, 59100
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Principal Investigator: Peiman Nazerian, MD Emergency Departmet Azienda Ospedaliero Universitaria Careggi

Publications:
Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, Di Saverio S, Ulrych J, Kluger Y, Ben-Ishay O, Moore FA, Ivatury RR, Coimbra R, Peitzman AB, Leppaniemi A, Fraga GP, Maier RV, Chiara O, Kashuk J, Sakakushev B, Weber DG, Latifi R, Biffl W, Bala M, Karamarkovic A, Inaba K, Ordonez CA, Hecker A, Augustin G, Demetrashvili Z, Melo RB, Marwah S, Zachariah SK, Shelat VG, McFarlane M, Rems M, Gomes CA, Faro MP, Júnior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Çolak E, Isik A, Rios-Cruz D, Soto R, Moore EE. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016 Jul 29;11:37. doi: 10.1186/s13017-016-0095-0. eCollection 2016. Review.

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Responsible Party: Peiman Nazerian, Principal Investigator, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03279588     History of Changes
Other Study ID Numbers: 11004
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi:
Ultrasound diagnosis
Abdominal Ultrasound
Emergency Department

Additional relevant MeSH terms:
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Abdominal Pain
Diverticulitis
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases