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
45 Years
75 Years
Both
Colorectal Adenoma
Trial Information
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.
Inclusion Criteria:
- Asymptomatic subjects aged 45 - 75 years
- Subjects who will give the written consent
Exclusion Criteria:
- Subjects with past history of colorectal cancer
- Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary
nonpolyposis colorectal cancer(HNPCC)
- Subjects with familial history of colorectal cancer more than 2 familial member in
direct line
- Subjects with inflammatory bowel disease(IBD)
- Subjects with more than 3 point of American Society of Anesthesiologists (ASA)
physical classification
- Subjects with past history of colectomy
- Subjects with history of colonoscopy within 5 years
- Subjects with history of sigmoidoscopy within 3 years
- Subjects with history of CT colonoscopy within 10 years
- Subjects with symptoms that could present the colorectal cancer such as hematochezia,
melena, weight loss more than 10kg/6months
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Advanced colorectal adenoma detection rate between two groups
Outcome Description:
We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.
Outcome Time Frame:
on 7 days after intervention
Safety Issue:
No
Principal Investigator
Hyun-Soo Kim, M.D., ph D.
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Authority:
Korea: Food and Drug Administration
Study ID:
CR312033
NCT ID:
NCT01767870
Start Date:
August 2012
Completion Date:
August 2015
Related Keywords:
- Colorectal Adenoma
- advanced colorectal adenoma
- colonoscopy
- sigmoidoscopy
- fecal immunochemical test
- Adenoma
- Neoplasms
Name | Location |
|---|
