ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

Scientific title

Prospective evaluation of Gastrointestinal Ultrasound on treatment course in patients admitted with moderate to severe ulcerative colitis

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

ulcerative colitis

inflammatory bowel disease

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Inflammatory and Immune System

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

By the end of hospital admission

Secondary outcome [1]

Nil

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2019

Date of last participant enrolment

Anticipated

Actual

16/12/2019

Date of last data collection

Anticipated

21/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004

Country [1]

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]

Hospital

Name [1]

Alfred Health

Address [1]

55 Commercial Road, Melbourne VIC 3004

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

Level 5, 553 St Kilda Rd 
Melbourne VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/04/2018

Approval date [1]

30/05/2018

Ethics approval number [1]

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

Dr Rebecca Smith

Address

Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0555

Fax

re.smith@alfred.org.au

Contact person for public queries

Name

Rebecca Smith

Address

Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0555

Fax

re.smith@alfred.org.au

Contact person for scientific queries

Name

Rebecca Smith

Address

Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0555

Fax

re.smith@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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.

Trial Review

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Documents added manually

Documents added automatically