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Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis

H

Hospital de Granollers

Status

Completed

Conditions

Acute Diverticulitis

Treatments

Diagnostic Test: Abdominal Ultrasonography
Diagnostic Test: Abdominal Computerized Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT05323968
HGG2017_3

Details and patient eligibility

About

Acute diverticulitis (AD) is the most common complication of diverticulosis and is divided into mild-moderate and complicated. Imaging methods are needed for its diagnosis, prognostic classification and therapeutic management. Currently the "gold-standard" imaging technique is computed tomography (CT) and most guidelines recommend it to classify and identify those patients with risk of treatment failure.

In this styudy, a prospective comparison of CT and abdominal ultrasound is proposed, with the aim of evaluating the diagnostic accuracy of ultrasound. An accurate ultrasound classification of AD would allow the differentiation of mild-moderate and complicated DA, avoiding routine CT and, therefore, patient's x-ray exposure.

Full description

Study design, setting and patients. Pragmatic prospective cohort study comparing the diagnostic accuracy of US and CT scan.

During a 17-month period patients referred to the imaging department with a clinical suspicion of acute LCD will be evaluated with US and CT.

Following the hospital care protocol, patients with suspected uncomplicated LCD will first undergo an abdominal US examination. Immediately after US examination, patients will be evaluated with CT.

In emergency cases in which complicated diverticulitis is suspected, the study will start with a CT, followed by ultrasound.

The interval between both exploration test will be in all cases less than 1 hour and will be performed before the administration of any anti-inflammatory or antibiotic treatment.

US and CT exams will be performed by three different radiologists with blinded results between them. All participating radiologists have more than five years of experience in abdominal radiology.

US examinations will be performed with a scanner Aplio 500 (Canon, Tokyo, Japan) employing convex and lineal transducer. CT studies will be performed on 6-MDCT scanner (SOMATOM Emotion Siemens, Germany) following the administration of 120ml of intravenous contrast.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical suspicion of acute diverticulitis

Exclusion criteria

  • Hemodynamic instability that prevents a diagnostic delay
  • Pregnant patients
  • Previous history of allergy to iodinated contrast

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

86 participants in 1 patient group

Acute diverticulitis
Other group
Description:
Patients with clinical suspicion of acute diverticulitis
Treatment:
Diagnostic Test: Abdominal Computerized Tomography
Diagnostic Test: Abdominal Ultrasonography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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