Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

Diagnostic Accuracy and Role of Bedside Ultrasound in Patients With 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

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Acute Diverticulitis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Emergency Department ASST degli Spedali Civili di Brescia
  • Prato, Italy, 59100
    • Emergency Department Nuovo Ospedale di Prato
  • Firenze
    • Figline Valdarno, Firenze, Italy
      • Department of Emergency Medicine
  • Tuscany
    • Firenze, Tuscany, Italy, 50134
      • Emergency Department Azienda Ospedaliera Universitaria Careggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of patient	To evaluate the reliability of the management proposed by the ultrasonographer on the basis of clinical, laboratoristic and ultrasonographic data.	30 days
Time reduction	To evaluate if the use of bedside abdominal US performed by Emergency Physicians can reduce the time needed for the diagnosis	30 days
CT scan reduction	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	30 days

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Peiman Nazerian, MD, Emergency Departmet Azienda Ospedaliero Universitaria Careggi

Publications and helpful links

General 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, Junior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Colak 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.
• Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068.
• Andeweg CS, Wegdam JA, Groenewoud J, van der Wilt GJ, van Goor H, Bleichrodt RP. Toward an evidence-based step-up approach in diagnosing diverticulitis. Scand J Gastroenterol. 2014 Jul;49(7):775-84. doi: 10.3109/00365521.2014.908475. Epub 2014 May 30.
• Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.
• Liljegren G, Chabok A, Wickbom M, Smedh K, Nilsson K. Acute colonic diverticulitis: a systematic review of diagnostic accuracy. Colorectal Dis. 2007 Jul;9(6):480-8. doi: 10.1111/j.1463-1318.2007.01238.x.
• Mazzei MA, Cioffi Squitieri N, Guerrini S, Stabile Ianora AA, Cagini L, Macarini L, Giganti M, Volterrani L. Sigmoid diverticulitis: US findings. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S5. doi: 10.1186/2036-7902-5-S1-S5. Epub 2013 Jul 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2017
• Primary Completion (ACTUAL): December 15, 2018
• Study Completion (ACTUAL): December 20, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 9, 2017
• First Posted (ACTUAL): September 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Emergency Department; Ultrasound diagnosis; Abdominal Ultrasound
• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Abdominal Pain; Diverticulitis
• Other Study ID Numbers: 11004 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No