Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

This arm (FIT-Sigmoidoscopy) will take fecal immunochemical test (FIT) followed by sigmoidoscopy for evaluation of advanced colorectal adenoma detection rate. Immediately after sigmoidoscopy, a total colonoscopy will be performed as a standard method for advanced colorectal adenoma detection.

This arm (Colonoscopy) will take a total colonoscopy as a control group that will represent the efficacy of colonoscopy for advanced colorectal adenoma detection rate.

Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy

FIT-sigmoidoscopy

Advanced colorectal adenoma detection by colonoscopy

Colonoscopy

Hyun-Soo Kim, M.D., ph D.

Hong Jun Park, M.D.

Hwang Choi, M.D., ph D.

Jeong Seon Ji, M.D.

Young Suk Cho, M.D.

Young-Eun Joo, M.D., ph D.

Jeong Eun Shin, M.D.

Eun Soo Kim, M.D.

Seong-Eun Kim, M.D.

Dong Il Park, M.D., ph D.

Jae Myung Cha, M.D., ph D.

Sung Noh Hong, M.D.

Seun-Ja Park, M.D., ph D.

Hyun Gun Kim, M.D.

Sung Pil Hong, M.D.

Jae Hak Kim, M.D.

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.

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.

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

We will evaluate adenoma detection rate and sessile serrated polyp detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.

We will evaluate missing adenoma rate of sigmoidoscopy on 7 dyas after sigmoidoscopy when pathologic diagnosis would be reported.

We will evaluated the characteristic of polyps which would be missed by sigmoidoscopy on 7 days after sigmoidoscopy when pathologic diagnosis would be reported.

We will evaluate the cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy on 7 days after colonoscopy when pathologic diagnosis would be reported.

We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy.

We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia	NCT01767870	Colorectal Aden...	FIT-sigmoidosco... Colonoscopy	45 Years - 75 Years	Yonsei University
Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia	NCT01767870	Colorectal Aden...	FIT-sigmoidosco... Colonoscopy	45 Years - 75 Years	Yonsei University
Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia	NCT01767870	Colorectal Aden...	FIT-sigmoidosco... Colonoscopy	45 Years - 75 Years	Yonsei University

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