Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

Sponsor

The Catholic University of Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT03623906

Collaborator

(none)

1,280

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Serrated Polyp	Procedure: Carbon dioxide insufflation colonoscopy Procedure: Air insufflation colonoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Aug 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carbon dioxide insufflation colonoscopy Carbon dioxide insufflation colonoscopy	Procedure: Carbon dioxide insufflation colonoscopy Carbon dioxide insufflation colonoscopy
Active Comparator: Air insufflation colonoscopy Room air insufflation colonoscopy	Procedure: Air insufflation colonoscopy Room air insufflation colonoscopy

Arm

Intervention/Treatment

Experimental: Carbon dioxide insufflation colonoscopy

Carbon dioxide insufflation colonoscopy

Procedure: Carbon dioxide insufflation colonoscopy

Carbon dioxide insufflation colonoscopy

Active Comparator: Air insufflation colonoscopy

Room air insufflation colonoscopy

Procedure: Air insufflation colonoscopy

Room air insufflation colonoscopy

Outcome Measures

Primary Outcome Measures

Serrated polyp detection rate [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy -

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Catholic University of Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong-Seon Ji, Dr, The Catholic University of Korea

ClinicalTrials.gov Identifier:

NCT03623906

Other Study ID Numbers:

First Posted:

Aug 9, 2018

Last Update Posted:

Aug 9, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polyps

Study Results

No Results Posted as of Aug 9, 2018