Comparing the Accuracy of Different Ultrasound-based Scores to Assess Disease Severity in Patients with Inflammatory Bowel Disease

November 23, 2024 updated by: Martina Mamdouh Zekry Ayoub, Assiut University

Comparing the Accuracy of Different Ultrasound -based Scores to Assess Disease Severity in Patients with Inflammatory Bowel Disease

Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity The aim of research is to compare between different ultrasound based scores used to assess disease severity in patients with inflammatory bowel disease to determine the most accurate score to be validated to use in clinical practice

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

  • Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity
  • IBD patients require repeat imaging throughout the course of their disease, necessitating a safe, noninvasive, available, and repeatable method. Imaging is required at diagnosis, routine surveillance, and acute flare of disease. Ultrasound imaging meets these demands with a high degree of accuracy and wide patient acceptance. Ultrasound provides high-resolution imaging and is excellent for detailed evaluation of the bowel wall and surrounding soft tissues performed without ionizing radiation with an extremely low risk of adverse contrast events compared to CT and MR Enterography which use ahigh dose of ionizing radiation, making it the frst choice of many Gastroenterologists and overwhelmingly preferred by patients

Several established IUS parameters are assessed during an IUS examination. These include bowel wall thickness (BWT); the stratification of the bowel wall layers, blood flow, luminal diameters, and motility, Additional extraintestinal surrogates to bowel inflammation to assess for include mesenteric fat proliferation and lymphadenopathy ,with proposal of different sonographic scoring systems in this domain to predict disease severity

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marwa mohammed samy, Associate professor
  • Phone Number: +20 01025260404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Sample size was calculated using the sample size calculator for sensitivity and specificity studies described by Dr Lin Naing @ Mohd. Ayub Sadiq (School of Dental Sciences, Universiti Sains Malaysia, Penang, Malaysia). Based on determining the main outcome variabble which is To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients and To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings According to the following inputs: expected sensitivity of the ultrasound in detecting IBD patients = 92%, expected Specificity =75%,*(9)* , desired precision = 6%, Confidence level = 80%. Sample size was 60 cases.Sample size was calculated using the sample size calculator for sensitivity and specificity studies described

Description

Inclusion Criteria:

- Adult patients aged 18-70 Confirmed diagnosis of Crohn's Disease or Ulcerative Colitis based on clinical, endoscopic, and histologic criteria

Exclusion Criteria:

  • Patients with other gastrointestinal diseases History of colectomy or proctocolectomy: Patients without a colon or rectum, which would limit the ability to assess IBD in those regions using ultrasound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare efficacy of different ultrasound scores to assess disease severity in IBD patients
Time Frame: Baseline

To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients.

To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings

.To identify the most reliable and practical ultrasound scoring system for routine clinical use
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 23, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 23, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Role of ultrasound in IBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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