NCT01767870

Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,282 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Colorectal Adenoma

Interventions

Type	Name	Description
PROCEDURE	FIT-sigmoidoscopy	Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
PROCEDURE	Colonoscopy	Advanced colorectal adenoma detection by colonoscopy

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-01-14
• Last updated: 2013-01-14

Locations

1 site across 1 country: South Korea