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

Sponsor
Hospital de Granollers (Other)
Overall Status
Completed
CT.gov ID
NCT05323968
Collaborator
(none)
86
1
1
45.5
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Abdominal Ultrasonography
  • Diagnostic Test: Abdominal Computerized Tomography
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Cohort study with comparison of two different diagnostic toolsCohort study with comparison of two different diagnostic tools
Masking:
None (Open Label)
Masking Description:
The two imaging examinations will be done by different radiologists blinded for the previous results.
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis: Prospective Cohort Study
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Aug 31, 2017
Actual Study Completion Date :
Jan 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Acute diverticulitis

Patients with clinical suspicion of acute diverticulitis

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of partcipants dignosed of having acute diverticulitis by Ultrasonography [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 [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 Outcome Measures

  1. Need of surgical operation [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) [During admission]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 FundaciĆ³ Privada Hospital Asil de Granollers Granollers Barcelona Spain 08402

Sponsors and Collaborators

  • Hospital de Granollers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Josep Maria Badia, Prof, Hospital de Granollers
ClinicalTrials.gov Identifier:
NCT05323968
Other Study ID Numbers:
  • HGG2017_3
First Posted:
Apr 12, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Josep Maria Badia, Prof, Hospital de Granollers
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022