Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

NCT03279588 | Completed

• 1 other identifier: 11004
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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

Conditions

Acute Diverticulitis; Abdominal Pain

Keywords

Ultrasound diagnosis; Abdominal Ultrasound; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Management of patient

  30 days

• Time reduction

  30 days

• CT scan reduction

  30 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (4)

Department of Emergency Medicine

Figline Valdarno, Firenze, Italy

Location

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Emergency Department ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Emergency Department Nuovo Ospedale di Prato

Prato, 59100, Italy

Location

Related Publications (6)

• 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.

  PMID: 27478494 BACKGROUND

• 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.

  PMID: 25360320 BACKGROUND

• 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.

  PMID: 24874087 BACKGROUND

• 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.

  PMID: 18523784 BACKGROUND

• 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.

  PMID: 17573739 BACKGROUND

• 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.

  PMID: 23902791 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

Study Officials

• Peiman Nazerian, MD

  Emergency Departmet Azienda Ospedaliero Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: May 20, 2017
• Primary Completion: December 15, 2018
• Study Completion: December 20, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)