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

NCT06705972 | Not Yet Recruiting DMC

• 1 other identifier: Role of ultrasound in IBD
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

inflammatory bowel disease,ultrasound,scoring

Outcome Measures

Primary Outcomes (1)

• To compare efficacy of different ultrasound scores to assess disease severity in IBD patients

  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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Rimola J, Torres J, Kumar S, Taylor SA, Kucharzik T. Recent advances in clinical practice: advances in cross-sectional imaging in inflammatory bowel disease. Gut. 2022 Dec;71(12):2587-2597. doi: 10.1136/gutjnl-2021-326562. Epub 2022 Aug 4.

  PMID: 35927032 BACKGROUND

• Valette PJ, Rioux M, Pilleul F, Saurin JC, Fouque P, Henry L. Ultrasonography of chronic inflammatory bowel diseases. Eur Radiol. 2001;11(10):1859-66. doi: 10.1007/s003300101065.

  PMID: 11702118 BACKGROUND

• Allocca M, Dell'Avalle C, Craviotto V, Furfaro F, Zilli A, D'Amico F, Bonovas S, Peyrin-Biroulet L, Fiorino G, Danese S. Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study. United European Gastroenterol J. 2022 Mar;10(2):190-197. doi: 10.1002/ueg2.12206. Epub 2022 Mar 1.

  PMID: 35233934 BACKGROUND

• Dragoni G, Gottin M, Innocenti T, Lynch EN, Bagnoli S, Macri G, Bonanomi AG, Orlandini B, Rogai F, Milani S, Galli A, Milla M, Biagini MR. Correlation of Ultrasound Scores with Endoscopic Activity in Crohn's Disease: A Prospective Exploratory Study. J Crohns Colitis. 2023 Oct 20;17(9):1387-1394. doi: 10.1093/ecco-jcc/jjad068.

  PMID: 37023010 BACKGROUND

• Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129.

  PMID: 32614386 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Martina Mamdouh zekry

CONTACT

drmartinamamdouh9@gmail.com; drmartinamamdouh9@gmail.com

Marwa mohammed samy, Associate professor

CONTACT

+20 01025260404

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share