Diagnostics in Diverticulitis (DIDit)

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT03443011

Collaborator

Centrallasarettet Västerås (Other), Mora Hospital, Landstinget Dalarna (Other)

149

Enrollment

Location

Arm

13.3

Actual Duration (Months)

11.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticulitis	Radiation: Low dose CT without intravenous contrast	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Diagnostics in Diverticulitis (DIDit)

Actual Study Start Date :

Jan 19, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Presence of diverticulitis on low dose CT and/or full dose CT [Baseline]
Colonic wall thickening >5mm, pericolic fat stranding and diverticula on CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Region Vastmanland Hospital	Vasteras	Vastmanland	Sweden	721 89

Sponsors and Collaborators

Uppsala University
Centrallasarettet Västerås
Mora Hospital, Landstinget Dalarna

Investigators

Study Director: Kenneth Smedh, Professor, Center for Clinical Reasearch Vasteras

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arnar Thorisson, Consulting radiologist, Uppsala University

ClinicalTrials.gov Identifier:

NCT03443011

Other Study ID Numbers:

Dnr 2016/411

First Posted:

Feb 22, 2018

Last Update Posted:

May 3, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diverticulitis

Study Results

No Results Posted as of May 3, 2018