Diagnostics in Diverticulitis (DIDit)
Primary Purpose
Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Low dose CT without intravenous contrast
Sponsored by
About this trial
This is an interventional diagnostic trial for Diverticulitis
Eligibility 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
Sites / Locations
- Region Vastmanland Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
participants
Arm Description
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
Outcomes
Primary Outcome Measures
Presence of diverticulitis on low dose CT and/or full dose CT
Colonic wall thickening >5mm, pericolic fat stranding and diverticula on CT
Secondary Outcome Measures
Full Information
NCT ID
NCT03443011
First Posted
December 26, 2016
Last Updated
May 2, 2018
Sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås, Mora Hospital, Landstinget Dalarna
1. Study Identification
Unique Protocol Identification Number
NCT03443011
Brief Title
Diagnostics in Diverticulitis (DIDit)
Official Title
Diagnostics in Diverticulitis (DIDit)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås, Mora Hospital, Landstinget Dalarna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Low dose CT without intravenous contrast
Intervention Description
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 Measure Information:
Title
Presence of diverticulitis on low dose CT and/or full dose CT
Description
Colonic wall thickening >5mm, pericolic fat stranding and diverticula on CT
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Smedh, Professor
Organizational Affiliation
Center for Clinical Reasearch Vasteras
Official's Role
Study Director
Facility Information:
Facility Name
Region Vastmanland Hospital
City
Vasteras
State/Province
Vastmanland
ZIP/Postal Code
721 89
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnostics in Diverticulitis (DIDit)
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