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Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

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ClinicalTrials.gov Identifier: NCT03623906
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Jeong-Seon Ji, The Catholic University of Korea

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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




Primary Outcome Measures :
  1. Serrated polyp detection rate [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Responsible Party: Jeong-Seon Ji, Dr, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03623906     History of Changes
Other Study ID Numbers: SDR
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical