Actively Recruiting
Led by Asian Institute of Gastroenterology, India · Updated on 2025-07-16
500
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the diagnostic accuracy of two different intestinal ultrasound machines—a high-end system (Samsung RS85) and a mid-end system (Siemens ACUSON S2000)—in detecting ileocolonic inflammation in patients with inflammatory bowel disease (IBD). This prospective, cross-sectional study uses ileo-colonoscopy as the reference standard and aims to determine if the more affordable mid-end machine can provide comparable results to the advanced high-end equipment. The study also looks at how ultrasound findings influence clinical management decisions and potential cost savings in healthcare settings with limited resources. Participants undergo two intestinal ultrasound examinations in the same session, one with each machine, performed by different specialists who are blinded to each other's results and colonoscopy findings. Ultrasound assessments measure bowel wall thickness, vascularity, and other disease markers. Within 24 hours, participants also have an ileo-colonoscopy to confirm disease activity. An independent panel reviews ultrasound findings to decide if treatment changes are justified. The study includes an economic analysis to assess cost-effectiveness of using mid-end ultrasound in routine care. During the study, participants receive clinical evaluation, two ultrasound scans, and a colonoscopy all within a short timeframe. Data collected includes detailed ultrasound and endoscopy results recorded on case report forms. Researchers measure diagnostic accuracy using sensitivity, specificity, positive predictive value, and negative predictive value. They also track changes in clinical management based on ultrasound findings. The total participation involves a single-day assessment, with results informing potential improvements in IBD diagnostic practices.
CONDITIONS
Comparing Diagnostic Accuracy of High-end Intestinal Ultrasound Versus Mid-end Ultrasound With Tandem Ileo-colonoscopy in Inflammatory Bowel Disease : a Paired, Validating Confirmatory Study
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo two intestinal ultrasound examinations using a high-end and a mid-end ultrasound machine in the same session to assess ileocolonic inflammation, followed by an ileo-colonoscopy within 24 hours as the reference standard.
1 visit including both ultrasound examinations and ileo-colonoscopy (in-person)
Duration - Within 24 hours after diagnostic evaluation
An independent physician panel reviews ultrasound findings within 24 hours to determine potential changes in clinical management based on the diagnostic results.
No additional visits required
Total: 1 location
1
Asian Institute of Gastroenterology
Hyderabad, Telangana, India, 500082
Actively Recruiting
P
Partha Pal, MD, DNB, MRCP (UK), FASGE
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Partha Pal, Mohammad Abdul Mateen, Syed Misba Naaz...
https://pubmed.ncbi.nlm.nih.gov/41969335