Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

August 6, 2018 updated by: Jeong-Seon Ji, The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1280

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serrated polyp detection rate
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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