NCT03443011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

January 19, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

December 26, 2016

Last Update Submit

May 2, 2018

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • Presence of diverticulitis on low dose CT and/or full dose CT

    Colonic wall thickening \>5mm, pericolic fat stranding and diverticula on CT

    Baseline

Study Arms (1)

participants

EXPERIMENTAL

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

Interventions

Low dose CT without intravenous contrastRADIATION

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.

participants

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Vastmanland Hospital

Västerås, Västmanland County, 721 89, Sweden

Location

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Kenneth Smedh, Professor

    Center for Clinical Reasearch Vasteras

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consulting radiologist

Study Record Dates

First Submitted

December 26, 2016

First Posted

February 22, 2018

Study Start

January 19, 2017

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

May 3, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)