Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

NCT ID: NCT03623906

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Serrated Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Carbon dioxide insufflation colonoscopy

Carbon dioxide insufflation colonoscopy

Group Type EXPERIMENTAL

Carbon dioxide insufflation colonoscopy

Intervention Type PROCEDURE

Carbon dioxide insufflation colonoscopy

Air insufflation colonoscopy

Room air insufflation colonoscopy

Group Type ACTIVE_COMPARATOR

Air insufflation colonoscopy

Intervention Type PROCEDURE

Room air insufflation colonoscopy

Interventions

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Carbon dioxide insufflation colonoscopy

Carbon dioxide insufflation colonoscopy

Intervention Type PROCEDURE

Air insufflation colonoscopy

Room air insufflation colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Seon Ji

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SDR

Identifier Type: -

Identifier Source: org_study_id

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