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NCT Number: NCT05323968

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

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.

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Key information

Conditions

Acute Diverticulitis Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundació Privada Hospital Asil de Granollers

Granollers, Barcelona, 08402, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal Ultrasonography

Diagnostic Test

The result of the Abdominal Ultrasonography will be compared with that of the Abdominal Computerized Tomography

Abdominal Computerized Tomography

Diagnostic Test

The result of the Abdominal Computerized Tomography will be compared with that of the Abdominal Ultrasonography

Primary outcomes

  1. Number of partcipants dignosed of having acute diverticulitis by Ultrasonography

    Time frame: First day of admission

    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).

  2. Number of partcipants dignosed of having acute diverticulitis by Computerized Tomography

    Time frame: First day of admission

    Identical imaging criteria for the diagnosis of acute diverticulitis will be used used , regardless of the image technique (US or CT).

Secondary outcomes

  1. Need of surgical operation

    Time frame: During admission

    Number of patients who undergo a surgical operation due to acute diverticulitis

  2. Need of a secong evaluation by diagnostic imaging (ultrasonography or computerized tomography)

    Time frame: During admission

    Number of patients not improving their clinical status during treatment and need a second image evaluation.

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Apr 12, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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