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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
Type of registration
Retrospectively registered
Titles & IDs
Public title
Prospective evaluation of Gastrointestinal Ultrasound in patients admitted with moderate to severe ulcerative colitis
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Scientific title
Prospective evaluation of Gastrointestinal Ultrasound on treatment course in patients admitted with moderate to severe ulcerative colitis
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Secondary ID [1]
301053
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis
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inflammatory bowel disease
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Condition category
Condition code
Oral and Gastrointestinal
315269
315269
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
315407
315407
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
317356
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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By the end of hospital admission
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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NA
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Eligibility
Key inclusion criteria
Patients admitted to hospital for a flare of suspected or confirmed ulcerative colitis requiring treatment with intravenous corticosteroids
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients unable to give informed consent
Pregnancy
Diagnosis of proctitis
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/05/2019
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Date of last participant enrolment
Anticipated
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Actual
16/12/2019
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Date of last data collection
Anticipated
21/12/2020
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Actual
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Sample size
Target
10
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
30039
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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The Alfred Hospital
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Address [1]
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The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004
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Country [1]
305496
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Australia
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Primary sponsor type
University
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Name
Monash University - Central Clinical School
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Address
The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Alfred Health
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Address [1]
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55 Commercial Road, Melbourne VIC 3004
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Country [1]
305893
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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Level 5, 553 St Kilda Rd Melbourne VIC
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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02/04/2018
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Approval date [1]
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30/05/2018
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Ethics approval number [1]
305807
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212/18
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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).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Rebecca Smith
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Address
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Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0555
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Rebecca Smith
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Address
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Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9903 0555
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
101668
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Rebecca Smith
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Address
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Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
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Country
101668
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Australia
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Phone
101668
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+61 3 9903 0555
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Fax
101668
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Email
101668
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7663
Ethical approval
379652-(Uploaded-17-04-2020-14-38-33)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Early Assessment With Gastrointestinal Ultrasound in Patients Hospitalised for a Flare of Ulcerative Colitis and Predicting the Need for Salvage Therapy: A Pilot Study.
2021
https://dx.doi.org/10.1016/j.ultrasmedbio.2020.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.
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