Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279588
• Other study ID #: 11004
• Status: Completed
• Start date: May 20, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: May 2019
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 20, 2018
• Est. primary completion date: December 15, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Acute Diverticulitis
• Diverticulitis

Intervention

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.

Locations

Country	Name	City	State
Italy	Emergency Department ASST degli Spedali Civili di Brescia	Brescia
Italy	Department of Emergency Medicine	Figline Valdarno	Firenze
Italy	Emergency Department Azienda Ospedaliera Universitaria Careggi	Firenze	Tuscany
Italy	Emergency Department Nuovo Ospedale di Prato	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Laméris 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. — View Citation

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. Review. — View Citation

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:S5. doi: 10.1186/2036-7902-5-S1-S5. Epub 2013 Jul 15. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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