Diagnostics in Diverticulitis (DIDit)
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|ClinicalTrials.gov Identifier: NCT03443011|
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diverticulitis||Radiation: Low dose CT without intravenous contrast||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostics in Diverticulitis (DIDit)|
|Actual Study Start Date :||January 19, 2017|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||March 1, 2018|
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 [ Time Frame: Baseline ]Colonic wall thickening >5mm, pericolic fat stranding and diverticula on CT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443011
|Region Vastmanland Hospital|
|Vasteras, Vastmanland, Sweden, 721 89|
|Study Director:||Kenneth Smedh, Professor||Center for Clinical Reasearch Vasteras|