Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis
Primary Purpose
Acute Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Abdominal Ultrasonography
Abdominal Computerized Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Diverticulitis focused on measuring Ultrasonography, Computed tomography, Accuracy, Sensitivity and specifity
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
Sites / Locations
- Fundació Privada Hospital Asil de Granollers
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Acute diverticulitis
Arm Description
Patients with clinical suspicion of acute diverticulitis
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Need of surgical operation
Number of patients who undergo a surgical operation due to acute diverticulitis
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323968
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Granollers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diverticulitis
Keywords
Ultrasonography, Computed tomography, Accuracy, Sensitivity and specifity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort 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.
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute diverticulitis
Arm Type
Other
Arm Description
Patients with clinical suspicion of acute diverticulitis
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal Ultrasonography
Intervention Description
The result of the Abdominal Ultrasonography will be compared with that of the Abdominal Computerized Tomography
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal Computerized Tomography
Intervention Description
The result of the Abdominal Computerized Tomography will be compared with that of the Abdominal Ultrasonography
Primary Outcome Measure Information:
Title
Number of partcipants dignosed of having acute diverticulitis by Ultrasonography
Description
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).
Time Frame
First day of admission
Title
Number of partcipants dignosed of having acute diverticulitis by Computerized Tomography
Description
Identical imaging criteria for the diagnosis of acute diverticulitis will be used used , regardless of the image technique (US or CT).
Time Frame
First day of admission
Secondary Outcome Measure Information:
Title
Need of surgical operation
Description
Number of patients who undergo a surgical operation due to acute diverticulitis
Time Frame
During admission
Title
Need of a secong evaluation by diagnostic imaging (ultrasonography or computerized tomography)
Description
Number of patients not improving their clinical status during treatment and need a second image evaluation.
Time Frame
During admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fundació Privada Hospital Asil de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08402
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis
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