Comparative Accuracy of Activity Scores of Intestinal Ultrasound and Colonoscopy in Monitoring Ulcerative Colitis Activity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AssessIUS Scores inUC Versus Colonoscopy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Our study aimed to assess simple sonographic activity scores and Colonoscopy for active UC patients
Detailed description
Ulcerative colitis (UC) has a relapsing-remitting course which necessitates frequent follow-up examinations to monitor disease activity.
Disease management was previously guided by patient reported symptoms, and treatment targets were based on symptom control. However, the patient's symptoms do not necessarily correspond to inflammatory activity and current guidelines recommend that management should be based on objective evaluations.
Ileocolonoscopy is considered the reference standard method for determining disease status in Ulcerative colitis. Although validated and reproducible scoring systems are complex and cumbersome to use in clinical practice, and even though ileocolonoscopy is an excellent tool for activity monitoring, it cannot be performed on a regular basis as it is invasive, is resourceintensive and causes considerable patient discomfort. As numerous follow-up examinations are required, simple non-invasive surrogate markers are needed.
Biomarkers such as C-reactive protein \[CRP\] and faecal calprotectin are well established in both primary work-up and disease monitoring.
Still, as they cannot depict disease location and have limited accuracy, additional tools are required.
Gastrointestinal ultrasound \[GIUS\] has high diagnostic accuracy for detecting active CD, and in trained hands, it can make significant impact on clinical decision-making.
Furthermore, as it is non-invasive, readily available and can be performed bedside, the modality seems well suited for bedside and frequent activity monitoring.
Still, interpretation of the GIUS findings may be influenced by the sonographer's level of experience. A standardized ultrasound activity index may simplify the interpretation of the sonographic findings, allowing for easier comparison between different examinations during follow-up. Although various sonographic activity scores are available, the methodology for development was shown to be insufficient in most studies and no index is in widespread clinical use.
Primary outcome measures
- Correlation Between Simple Sonographic Activity Scores and Colonoscopy Findings in Active Ulcerative Colitis [Time frame: At baseline (Day 0) from hospital admission]
- Assessment of Sonographic Activity Scores Compared to Colonoscopy in Active Ulcerative Colitis Patients [Time frame: At baseline (Day 0 of hospital admission)]
Eligibility criteria
Inclusion criteria
- Any patient above age of 18 years old and diagnosed to have active UC through:
- Clinical features: rectal bleeding, with frequent stools and mucous discharge from the rectum. Some patients also describe tenesmus. The onset is typically insidious.
- Endoscopic findings include the following; loss of vascular pattern, Granular and fragile mucosa, friability, ulcerations, erosions, pseudo-polyposis
Exclusion criteria
- Patients with UC who are under age of 18 years' old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07115524 · 4-2025-300644