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Trial registered on ANZCTR


Registration number
ACTRN12620000569909
Ethics application status
Approved
Date submitted
17/04/2020
Date registered
15/05/2020
Date last updated
15/05/2020
Date data sharing statement initially provided
15/05/2020
Date results information initially provided
15/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective evaluation of Gastrointestinal Ultrasound in patients admitted with moderate to severe ulcerative colitis
Scientific title
Prospective evaluation of Gastrointestinal Ultrasound on treatment course in patients admitted with moderate to severe ulcerative colitis
Secondary ID [1] 301053 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis 317105 0
inflammatory bowel disease 317106 0
Condition category
Condition code
Oral and Gastrointestinal 315269 315269 0 0
Inflammatory bowel disease
Inflammatory and Immune System 315407 315407 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients admitted to hospital with a flare of ulcerative colitis will be monitored with gastrointestinal ultrasound (GIUS). They will undergo a detailed assessment with GIUS within 24 hours of hospital admission and again by Day 3 of the admission and at Day 7 of hospital admission (if relevant). Detailed assessment of baseline characteristics of the individuals enrolled will be recorded. Daily bloods tests, clinical symptoms and progress and any treatment interventions will be documented. Results of the routine endoscopic assessment will also be recorded. Faecal calprotectin samples will be obtained from patients and quality of life questionnaire will be completed.

At discharge from hospital - routine follow up appointments will occur at 2 weeks and 3 monthly up to a year. Each follow up appointment will involve GIUS, review of clinical symptoms, blood tests, faecal calprotectin tests and quality of life questionnaires. GIUS is readily available for monitoring disease activity of patients with inflammatory bowel disease including ulcerative colitis. It is frequently used in the outpatient setting in hospitals that are experienced in this technique, however its role in the inpatient setting and in predicting treatment outcomes in acute severe flares, is yet to be defined. Of note, each GIUS assessment is performed by two independent gastroenterologists as part of this study.
Intervention code [1] 317356 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323512 0
To assess if gastrointestinal ultrasound findings differ between individuals who are steroid responsive compared to those requiring salvage therapy during hospital admission, as assessed by medical records.
Timepoint [1] 323512 0
By the end of hospital admission
Secondary outcome [1] 382106 0
Nil
Timepoint [1] 382106 0
NA

Eligibility
Key inclusion criteria
Patients admitted to hospital for a flare of suspected or confirmed ulcerative colitis requiring treatment with intravenous corticosteroids
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to give informed consent
Pregnancy
Diagnosis of proctitis

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16489 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 30039 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305496 0
Hospital
Name [1] 305496 0
The Alfred Hospital
Address [1] 305496 0
The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004
Country [1] 305496 0
Australia
Primary sponsor type
University
Name
Monash University - Central Clinical School
Address
The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 305893 0
Hospital
Name [1] 305893 0
Alfred Health
Address [1] 305893 0
55 Commercial Road, Melbourne VIC 3004
Country [1] 305893 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305807 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 305807 0
Level 5, 553 St Kilda Rd
Melbourne VIC
Ethics committee country [1] 305807 0
Australia
Date submitted for ethics approval [1] 305807 0
02/04/2018
Approval date [1] 305807 0
30/05/2018
Ethics approval number [1] 305807 0
212/18

Summary
Brief summary
Patients admitted to hospital requiring intravenous corticosteroids for management of their ulcerative colitis will be prospectively recruited for this observational study.
The medical management of the patient in hospital and timing of further investigations will be guided by the treating clinician and not by the study investigators. Patients specific treatment in hospital will be recorded. Blood tests, which are part of routine care will be recorded daily.
The clinical symptoms of the patient will be recorded daily with a standardised clinical tool. Furthermore, we will collect faecal calprotectin as part of the biochemical screening. The results of the inpatient flexible sigmoidoscopy or colonoscopy will graded with validated endoscopic assessment scores. The findings of the endoscopic assessment will be blinded to the clinicians performing the gastrointestinal ultrasound (GIUS) assessment. GIUS is a non invasive ultrasound assessment that can accurately detect disease activity in inflammatory bowel disease, including patients with ulcerative colitis. The GIUS assessment will be detailed
looking at the standard features used to assess disease activity in IBD such as bowel wall thickness, colour Doppler, wall stratification assessment, haustration assessment and extra intestinal features of inflammation. GIUS will occur within 24 hours of IV corticosteroid initiation and at 48 hours. If the patient remains in hospital at 7 days, the GIUS will be repeated. Follow up will occur at 2 weeks, and then 3 monthly up until 1 year. The aim is to predict if gastrointestinal ultrasound findings can predict the treatment course of admitted patients ie. steroid responsive individuals vs. steroid non-responsive (patients requiring salvage therapy).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101666 0
Dr Rebecca Smith
Address 101666 0
Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
Country 101666 0
Australia
Phone 101666 0
+61 3 9903 0555
Fax 101666 0
Email 101666 0
re.smith@alfred.org.au
Contact person for public queries
Name 101667 0
Dr Rebecca Smith
Address 101667 0
Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
Country 101667 0
Australia
Phone 101667 0
+61 3 9903 0555
Fax 101667 0
Email 101667 0
re.smith@alfred.org.au
Contact person for scientific queries
Name 101668 0
Dr Rebecca Smith
Address 101668 0
Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
Country 101668 0
Australia
Phone 101668 0
+61 3 9903 0555
Fax 101668 0
Email 101668 0
re.smith@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7663 0
Ethical approval
Citation [1] 7663 0
Link [1] 7663 0
Email [1] 7663 0
Other [1] 7663 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary