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NCT Number: NCT07115524

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

Our study aimed to assess simple sonographic activity scores and Colonoscopy for active UC patients

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation Between Simple Sonographic Activity Scores and Colonoscopy Findings in Active Ulcerative Colitis

    Time frame: At baseline (Day 0) from hospital admission

    To 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.

  2. Assessment of Sonographic Activity Scores Compared to Colonoscopy in Active Ulcerative Colitis Patients

    Time frame: At 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira M Abdelmawgod, Lecturer, Tropical Medicine

CONTACT

[email protected]

+201012760437

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: IUS/IBD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.