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Diagnostics in Diverticulitis (DIDit)

Diagnostics in Diverticulitis (DIDit)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03443011
Enrollment
149
Registered
2018-02-22
Start date
2017-01-19
Completion date
2018-03-01
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticulitis

Brief summary

This study focuses on if low dose CT without intravenous contrast has a high enough specificity and sensitivity for acute diverticulitis that it can be used as the primary diagnostic method instead of a full dose CT with intravenous contrast which is the standard method in Sweden.

Detailed description

Patients will be recruited from the emergency departments in Mora and Vastmanland hospitals. All patients over the age of 50 with clinically suspected acute diverticulitis that meet inclusions criterium will be asked for participation. A Clinical examination and blood samples will be drawn. Subjects will be sent to the radiology department where they will undergo computed tomography (CT) of the abdomen. The CT protocol consists of a low dose non contrast enhanced CT followed by a normal dose CT with intravenous contrast. This is needed as randomization of patients is not possible due to the fact that the Clinical diagnosis of diverticulitis is difficult and unreliable. This would lead to the situation that we would not know if a participant in the low dose CT Group has diverticulitis which was not seen with the low dose protocol or if the patient did not have diverticulitis. The radiologist on call will examine the full dose CT examination and write a report as routine. At a later date Three blinded radiologists will examine first all low dose CT examinations and grade them according to our CT protocol. At a later date the radiologists will evaluate all full dose CT examinations using the same CT protocol. Findings will then be compared between the two different CT methods and sensitivity and specificity for low dose CT will be calculated.

Interventions

RADIATIONLow dose CT without intravenous contrast

participants will receive an extra radiation dosage of about 3 milli Sievert (mSv) depending on patients height and weight. This is the radiation amount from the low dose CT protocol without intravenous contrast.

Sponsors

Centrallasarettet Västerås
CollaboratorOTHER
Mora Hospital, Landstinget Dalarna
CollaboratorUNKNOWN
Uppsala University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Over the age of 50 * Clinically suspected acute diverticulitis * Low abdominal pain * WBC over 10 x 109/L or raised C-reactive protein levels 25 mg/L

Exclusion criteria

* Pregnancy * Previous allergy to intravenous contrast * Renal failure or other reasons that the patient cannot undergo CT with iv contrast * Unable to give informed consent * Dementia * Language barrier

Design outcomes

Primary

MeasureTime frameDescription
Presence of diverticulitis on low dose CT and/or full dose CTBaselineColonic wall thickening \>5mm, pericolic fat stranding and diverticula on CT

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026