Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation
Comparison of Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation During Colonoscopy: a Randomized Controlled Multicenter Trial
1 other identifier
interventional
1,280
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 9, 2018
August 1, 2018
2 years
August 6, 2018
August 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Serrated polyp detection rate
7 days
Study Arms (2)
Carbon dioxide insufflation colonoscopy
EXPERIMENTALCarbon dioxide insufflation colonoscopy
Air insufflation colonoscopy
ACTIVE COMPARATORRoom air insufflation colonoscopy
Interventions
Carbon dioxide insufflation colonoscopy
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 9, 2018
Study Start
September 1, 2018
Primary Completion
August 31, 2020
Study Completion
December 31, 2020
Last Updated
August 9, 2018
Record last verified: 2018-08