Clinical trial NCT06165328: The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+
Official title: The Comparison of Diagnostic Yield Between Routine Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients Who at Risk of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients at Risk of Colorectal Cancer
Keywords: colorectal tumor
colorectal cancer
CT scan
colonoscopy
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
Collaborators: name: HatYai Hospital
First posted: 2023-12-11
Enrollment: 241
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 50-70 years old who underwent FIT test for an indication of colorectal cancer screening as National program of Thailand.

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

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield in diagnosis colorectal tumor
timeFrame: 2 weeks
Secondary outcomes:
measure: Procedure-related adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Hatyai Hospital
state: Songkhla
Study officials:
affiliation: Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital
name: Arunchai Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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