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

NCT05323968 | Completed

• 1 other identifier: HGG2017_3
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diverticulitis

Keywords

Ultrasonography; Computed tomography; Accuracy; Sensitivity and specifity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Need of surgical operation

  During admission

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

  During admission

Study Arms (1)

Acute diverticulitis

OTHER

Patients with clinical suspicion of acute diverticulitis

Diagnostic Test: Abdominal Ultrasonography; Diagnostic Test: Abdominal Computerized Tomography

Interventions

Abdominal Ultrasonography DIAGNOSTIC_TEST

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

Acute diverticulitis

Abdominal Computerized Tomography DIAGNOSTIC_TEST

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

Acute diverticulitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical suspicion of acute diverticulitis

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Fundació Privada Hospital Asil de Granollers

Granollers, Barcelona, 08402, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The two imaging examinations will be done by different radiologists blinded for the previous results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Cohort study with comparison of two different diagnostic tools

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: January 15, 2020
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)