NCT03623906

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 6, 2018

Last Update Submit

August 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serrated polyp detection rate

    7 days

Study Arms (2)

Carbon dioxide insufflation colonoscopy

EXPERIMENTAL

Carbon dioxide insufflation colonoscopy

Procedure: Carbon dioxide insufflation colonoscopy

Air insufflation colonoscopy

ACTIVE COMPARATOR

Room air insufflation colonoscopy

Procedure: Air insufflation colonoscopy

Interventions

Carbon dioxide insufflation colonoscopy

Carbon dioxide insufflation colonoscopy

Room air insufflation colonoscopy

Air insufflation colonoscopy

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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