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NCT03623906 Clinical Trial

Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

Serrated Polyp Clinical Trial

Official title:
Comparison of Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation During Colonoscopy: a Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03623906
Other study ID # SDR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2020

Study information
Verified date August 2018
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sessile serrated adenomas are characterized by their flat shape and the presence of a yellow mucus cap overlying the lesion. These morphological features may account for their diagnostic difficulty during colonoscopy. Missed proximal sessile serrated adenomas are regarded as an important cause for interval cancers in the right colon and emphasize the importance of developing quality measures intended to enhance their detection. There is only one single-center retrospective cohort study on the impact of carbon dioxide insufflation on the detection of serrated polyps during colonoscopy. The investigators designed a randomized, controlled trial to compare the effect of carbon dioxide insufflation vs. room air insufflation on serrated polyp detection rate.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1280
Est. completion date December 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy -

Exclusion Criteria:polyposis syndrome, Inflammatory bowel disease, previous colorectal operation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Carbon dioxide insufflation colonoscopy
Carbon dioxide insufflation colonoscopy
• Air insufflation colonoscopy
Room air insufflation colonoscopy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Catholic University of Korea

Outcome
Type Measure Description Time frame Safety issue
Primary Serrated polyp detection rate 7 days
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