Clinical Trial: Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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
Brief Summary: The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.
Detailed Summary:
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.
Sponsor: Yonsei University
Current Primary Outcome: Advanced colorectal adenoma detection rate between two groups [ Time Frame: on 7 days after intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Sensitivity of fecal immunochemical test for advanced colorectal adenoma [ Time Frame: on 7days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
- Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- positive predictive valueof fecal immunochemical test for advanced colorectal adenoma [ Time Frame: on 7days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
- specificity of fecal immunochemical test for advanced colorectal adenoma [ Time Frame: on 7days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
- negative predictive value of fecal immunochemical test for advanced colorectal adenoma [ Time Frame: on 7days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
- specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
- negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer [ Time Frame: on 7 days after intervention ]We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colo
Original Secondary Outcome: Same as current
Information By: Yonsei University
Dates:
Date Received: December 19, 2012
Date Started: August 2012
Date Completion: August 2015
Last Updated: January 10, 2013
Last Verified: January 2013
