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Comparative Accuracy of Activity Scores of Intestinal Ultrasound and Colonoscopy in Monitoring Ulcerative Colitis Activity

Comparative Accuracy of Activity Scores of Intestinal Ultrasound and Colonoscopy in Monitoring Ulcerative Colitis Activity

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07115524
Acronym
IUS/IBD
Enrollment
200
Registered
2025-08-11
Start date
2026-09-01
Completion date
2027-09-01
Last updated
2026-01-13

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

Conditions

AssessIUS Scores inUC Versus Colonoscopy

Brief summary

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation Between Simple Sonographic Activity Scores and Colonoscopy Findings in Active Ulcerative ColitisAt baseline (Day 0) from hospital admissionTo evaluate the relationship between intestinal ultrasound (IUS)-based sonographic activity scores and endoscopic disease activity assessed by colonoscopy in patients with active ulcerative colitis. The aim is to determine whether sonographic scoring can serve as a non-invasive surrogate for endoscopic assessment in monitoring disease activity.
Assessment of Sonographic Activity Scores Compared to Colonoscopy in Active Ulcerative Colitis PatientsAt baseline (Day 0 of hospital admission)To evaluate the diagnostic accuracy and clinical relevance of simple intestinal ultrasound (IUS) activity scores in assessing disease activity in patients with active ulcerative colitis (UC), using colonoscopy findings as the reference standard.

Contacts

Primary ContactAmira M Abdelmawgod, Lecturer, Tropical Medicine
amiramohmad60@gmail.com+201012760437

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026