Acute DiverticulitisNCT05323968
Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis
A study testing Abdominal Ultrasonography and Abdominal Computerized Tomography in people with Acute Diverticulitis, run by Hospital de Granollers at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Abdominal Ultrasonography and Abdominal Computerized Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2016to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of acute diverticulitis
Who cannot join
- Hemodynamic instability that prevents a diagnostic delay
- Pregnant patients
- Previous history of allergy to iodinated contrast
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Privada Hospital Asil de Granollers
Granollers, Barcelona, 08402
About this study
Official title: Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis: Prospective Cohort Study
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.
Read the 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.
- Conditions
- Acute Diverticulitis
- Being tested
- Abdominal Ultrasonography, Abdominal Computerized Tomography
- Keywords
- Ultrasonography, Computed tomography, Accuracy, Sensitivity and specifity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal UltrasonographyDiagnostic test
The result of the Abdominal Ultrasonography will be compared with that of the Abdominal Computerized Tomography
Abdominal Computerized TomographyDiagnostic test
The result of the Abdominal Computerized Tomography will be compared with that of the Abdominal Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Acute diverticulitis | Other | Patients with clinical suspicion of acute diverticulitis Receives: Diagnostic Test: Abdominal Ultrasonography; Diagnostic Test: Abdominal Computerized Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: First day of admission
Secondary outcomes (2)
Need of surgical operation
Number of patients who undergo a surgical operation due to acute diverticulitis
Measured: 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.
Measured: During admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Apr 2016
- Primary completion31 Aug 2017
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study with comparison of two different diagnostic tools
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Maria Badia, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323968
- Sponsor's protocol ID
- HGG2017_3
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roson N, Antolin A, Flores-Yelamos M, Garriga MV, Pruna X, Pedraza S, Lopez-Cano M, Badia JM. Ultrasonography for suspected mild-to-moderate acute left colonic diverticulitis: a prospective head-to-head study with computed tomography. Front Radiol. 2026 May 28;6:1829813. doi: 10.3389/fradi.2026.1829813. eCollection 2026.
PubMed 42294473
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05323968
- Acronym / sponsor ID
- HGG2017_3
- Conditions
- Acute Diverticulitis
- Keywords
- Ultrasonography, Computed tomography, Accuracy, Sensitivity and specifity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study with comparison of two different diagnostic tools
| Arm | Type | Receives |
|---|---|---|
| Acute diverticulitis | Other | Diagnostic Test: Abdominal Ultrasonography, Diagnostic Test: Abdominal Computerized TomographyPatients with clinical suspicion of acute diverticulitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical suspicion of acute diverticulitis
Key exclusion criteria (3 listed)
- Hemodynamic instability that prevents a diagnostic delay
- Pregnant patients
- Previous history of allergy to iodinated contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal UltrasonographyThe result of the Abdominal Ultrasonography will be compared with that of the Abdominal Computerized Tomography | Diagnostic test | Acute diverticulitis |
| Abdominal Computerized TomographyThe result of the Abdominal Computerized Tomography will be compared with that of the Abdominal Ultrasonography | Diagnostic test | Acute diverticulitis |
Primary outcome
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).
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).
2 secondary outcomes
Need of surgical operation
Time frame: During admission
Need of a secong evaluation by diagnostic imaging (ultrasonography or computerized tomography)
Time frame: During admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 42294473Roson N, Antolin A, Flores-Yelamos M, Garriga MV, Pruna X, Pedraza S, Lopez-Cano M, Badia JM. Ultrasonography for suspected mild-to-moderate acute left colonic diverticulitis: a prospective head-to-head study with computed tomography. Front Radiol. 2026 May 28;6:1829813. doi: 10.3389/fradi.2026.1829813. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Ultrasonography and Abdominal Computerized Tomography in people with Acute Diverticulitis, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of partcipants dignosed of having acute diverticulitis by Ultrasonography (time frame: First day of admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.