Clinical trial NCT05323968: Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis
Official title: Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis: Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Diverticulitis
Keywords: Ultrasonography
Computed tomography
Accuracy
Sensitivity and specifity
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study with comparison of two different diagnostic tools
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of partcipants dignosed of having acute diverticulitis by Ultrasonography
timeFrame: First day of admission
measure: Number of partcipants dignosed of having acute diverticulitis by Computerized Tomography
timeFrame: First day of admission
Secondary outcomes:
measure: Need of surgical operation
timeFrame: During admission
measure: Need of a secong evaluation by diagnostic imaging (ultrasonography or computerized tomography)
timeFrame: During admission
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Fundació Privada Hospital Asil de Granollers
state: Barcelona
Study officials:
References: