Efficacy and Cost-effectiveness of Colonoscopy vs. Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (eCOLO-FITS): A Randomized Multicenter Trial
The investigators will evaluate the efficacy of FITS for the detection of advanced
colorectal neoplasia compared to colonoscopy. This study was designed as multicenter
randomized interventional study. The expected period are 36months. A total 13 tertiary
hospitals will participate in the study.
Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who
undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In
colonoscopy group, subjects as a control group would be performed colonoscopy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Advanced colorectal adenoma detection rate between two groups
We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.
on 7 days after intervention
Hyun-Soo Kim, M.D., ph D.
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Korea: Food and Drug Administration