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
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.
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.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 149 is above the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Jan 2018, 11 months.
Of 16 interventional studies with no phase under Diverticulitis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 11 months is below that.
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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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