Clinical Trials Directory

Trials / Completed

CompletedNCT03443011

Diagnostics in Diverticulitis (DIDit)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
149 (actual)
Sponsor
Uppsala University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONLow dose CT without intravenous contrastparticipants 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.

Timeline

Start date
2017-01-19
Primary completion
2018-01-01
Completion
2018-03-01
First posted
2018-02-22
Last updated
2018-05-03

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03443011. Inclusion in this directory is not an endorsement.