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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000569909
Enrollment
10
Registered
2020-05-15
Start date
2019-05-01
Completion date
2019-12-16
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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. Resul

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.

Sponsors

Monash University - Central Clinical School
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients admitted to hospital for a flare of suspected or confirmed ulcerative colitis requiring treatment with intravenous corticosteroids

Exclusion criteria

Patients unable to give informed consent Pregnancy Diagnosis of proctitis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026