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Clinical Trials/NCT06165328
NCT06165328
Recruiting
Not Applicable

The Comparison of Diagnostic Yield Between Routine Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients Who at Risk of Colorectal Cancer

Hat Yai Medical Education Center1 site in 1 country241 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients at Risk of Colorectal Cancer
Sponsor
Hat Yai Medical Education Center
Enrollment
241
Locations
1
Primary Endpoint
Diagnostic yield in diagnosis colorectal tumor
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Colonoscopy is the mainstay modality of choice in colorectal cancer screening worldwide. However, the rate of colonoscopy for colorectal cancer screening is very low (approximately 5-10%) because of the limited local medical resources (such as endoscopists and regional endoscope). This observational diagnostic test study aims to compare the diagnostic yield of routine computed tomography and colonoscopy in detecting colorectal tumors in patients at risk of colorectal cancer (aged more than 50 years and FIT+). The main question[s] it aims to answer are:

  1. To compare the diagnostic yield between the routine computed tomography and colonoscopy.
  2. To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.

Detailed Description

All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arunchai Chang

Head of Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital

Hat Yai Medical Education Center

Eligibility Criteria

Inclusion Criteria

  • Normal platelet count and normal result of PT, PTT

Exclusion Criteria

  • pregnancy or lactation
  • uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
  • recent coronary artery disease within 3 months
  • eGFR lesser than 30 mL/min/1.73m2
  • hemophilia or uncontrolled or uncorrected coagulopathy

Outcomes

Primary Outcomes

Diagnostic yield in diagnosis colorectal tumor

Time Frame: 2 weeks

Sensitivity, specitivity, accuracy

Secondary Outcomes

  • Procedure-related adverse events(2 weeks)

Study Sites (1)

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