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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis: Prospective Cohort Study

Conditions
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Acute Diverticulitis

Intervention / Treatment
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* Diagnostic Test: Abdominal Ultrasonography
* Diagnostic Test: Abdominal Computerized Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort study with comparison of two different diagnostic tools
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acute diverticulitis<br>Patients with clinical suspicion of acute diverticulitis | Diagnostic Test: Abdominal Ultrasonography<br>* The result of the Abdominal Ultrasonography will be compared with that of the Abdominal Computerized Tomography<br>Diagnostic Test: Abdominal Computerized Tomography<br>* The result of the Abdominal Computerized Tomography will be compared with that of the Abdominal Ultrasonography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of partcipants dignosed of having acute diverticulitis by Ultrasonography | Identical imaging criteria for the diagnosis of acute diverticulitis will be used used , regardless of the image technique (US or CT). Following the Neff modified classification, the minimum findings to take in to account will bethe presence of diverticula and mural thickening, alone or associated with inflammation of the pericolic fat (Stage 0). Mural thickening will be considered when colonic wall has 4mm or more. Other findings will be: localized pneumoperitoneum depicted by air bubbles (Stage Ia), and abscess < 4cm (Stage Ib). Stage Ia and Ib will be considered as locally complicated diverticulitis. Findings considered as belonging to complicated diverticulitis will be: pelvic abscess > 4cm (Stage II), an intra-abdominal abscess outside the pelvis (Stage III), or difuse pneumoperitoneum and intra-abdominal free liquid (Stage IV). | First day of admission | 
| Number of partcipants dignosed of having acute diverticulitis by Computerized Tomography | Identical imaging criteria for the diagnosis of acute diverticulitis will be used used , regardless of the image technique (US or CT). | First day of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of surgical operation | Number of patients who undergo a surgical operation due to acute diverticulitis | During admission | 
| Need of a secong evaluation by diagnostic imaging (ultrasonography or computerized tomography) | Number of patients not improving their clinical status during treatment and need a second image evaluation. | During admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Computed tomography, Accuracy, Sensitivity and specifity