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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
Sponsor:
Collaborators:
Centrallasarettet Västerås
Mora Hospital, Landstinget Dalarna
Information provided by (Responsible Party):
Arnar Thorisson, Uppsala University

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.

Condition or disease Intervention/treatment Phase
Diverticulitis Radiation: Low dose CT without intravenous contrast Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sweden
Region Vastmanland Hospital
Vasteras, Vastmanland, Sweden, 721 89
Sponsors and Collaborators
Uppsala University
Centrallasarettet Västerås
Mora Hospital, Landstinget Dalarna
Investigators
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Study Director: Kenneth Smedh, Professor Center for Clinical Reasearch Vasteras

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Responsible Party: Arnar Thorisson, Consulting radiologist, Uppsala University
ClinicalTrials.gov Identifier: NCT03443011     History of Changes
Other Study ID Numbers: Dnr 2016/411
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases