The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+

Recruiting

• Conditions: Patients at Risk of Colorectal Cancer
• Interventions: Diagnostic Test: CT and colonoscopy

• Registration Number: NCT06165328
• Lead Sponsor: Hat Yai Medical Education Center

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

Study Timeline

• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-02
• Study First Posted: 2023-12-11
• Study Start: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

1. Fit test +
2. Normal platelet count and normal result of PT, PTT

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort1	CT and colonoscopy	Patients with aged more than 50 years and had FIT test +

Primary Outcome Measures

Name	Time	Method
Diagnostic yield in diagnosis colorectal tumor	2 weeks	Sensitivity, specitivity, accuracy

Secondary Outcome Measures

Name	Time	Method
Procedure-related adverse events	2 weeks	Procedure-related adverse events such as, contrast induced nephropathy, contrast allergy, colonoscope-related perforation, post polypectomy bleeding

Trial Locations

Locations (1)

Hatyai Hospital; 🇹🇭 Hat Yai, Songkhla, Thailand