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CompletedNCT03443011Updated May 3, 2018

Diagnostics in Diverticulitis (DIDit)

An interventional study of Low dose CT without intravenous contrast in Diverticulitis, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by Uppsala University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
149
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diverticulitis

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03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    participants

    All participants will be examined with both CT techniques. First a low dose CT without intravenous contrast followed by the standard method, a full dose CT with intravenous contrast

    Radiation: Low dose CT without intravenous contrast

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.

05

What researchers measure

Primary outcomes

  1. Presence of diverticulitis on low dose CT and/or full dose CT

    Colonic wall thickening \>5mm, pericolic fat stranding and diverticula on CT

    Time frame: Baseline

06

Study locations

1 site
  • Region Vastmanland Hospital
    Vasteras, Vastmanland 721 89, Sweden
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03443011
Lead sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås, Mora Hospital, Landstinget Dalarna
Responsible party
Arnar Thorisson (Consulting radiologist, Uppsala University) — Principal investigator
First posted
Feb 22, 2018
Start date
Jan 19, 2017
Primary completion
Jan 1, 2018
Completion
Mar 1, 2018
Last update
May 3, 2018

Study contacts

Kenneth Smedh, Professor
study director · Center for Clinical Reasearch Vasteras

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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