The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyp. This study will be performed using web-based research network, e-VELOS in Korea.
Various endoscopic tools have been tried to reduce polyp missing rate which has been reported to be 20-25%. Transparent cap-assisted colonoscopy has been suggested to improve visualization of the lesion that are difficult to access, such as tangentially located lesions and those located within a limited luminal space. Chromoendoscopy with indigocarmine spraying was reported to increases the detection rates of polyp, especially in right colon and rectum. However, there also have been mixed results regarding polyp detection rates of the endoscopic methods. Moreover, there is no data regarding the impact of the screening tools on longterm recurrence rate of colorectal polyp. Therefore, in this study, we intend to perform a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyps. This study will be performed using web-based research network, e-VELOS in Korea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,905
A cap (irrigation cap) is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. For chromoendoscopy, 0.09% indigocarmine was administered via irrigation cap .
Hallym University Medical Center
Anyang, South Korea
Kosin University College of Medicine
Busan, South Korea
Dankuk University college of medicine hospital
Adenoma detection rate
The proportion of subjects with at least one adenoma
Time frame: 7 days is needed to confirm the pathologic examination.
Proximal adenoma detection rate
Proportion of subjects with at least one proximal colon adenoma
Time frame: 7 days is needed to confirm the pathologic examination.
Proximal serrated polyp detection rate
Proportion of subjects with at least one proximal serrated polyp/adenoma
Time frame: 7 days is needed to confirm the pathologic examination.
Advanced adenoma detection rate
Proportion of subjects with at least one advanced adenoma
Time frame: 7 days is needed to confirm the pathologic examination.
Serrated adenoma detection rate
Proportion of subjects with at least one serrated adenoma
Time frame: 7 days is needed to confirm the pathologic examination.
Cancer detection rate
Proportion of subjects with at least one cancer
Time frame: 7 days is needed to confirm the pathologic examination.
Surveillance
Surveillance interval recommendations for both groups were classified based on adenoma detection
Time frame: 7 - 14 days
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Cheonan, South Korea
National Cancer Center Hospital, National Cancer Center
Goyang, South Korea
Hanyang University Guri Hospital, Hanyang University College of Medicine
Guri-si, South Korea
Catholic university St. Mari's hospital
Incheon, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Ewha Mokdong hospital
Seoul, South Korea
Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
Seoul, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
...and 4 more locations