Serrated PolypNCT03623906
Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation
A study testing Carbon dioxide insufflation colonoscopy and Air insufflation colonoscopy in people with Serrated Polyp, run by The Catholic University of Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Serrated Polyp
- What is being tested?
- Carbon dioxide insufflation colonoscopy and Air insufflation colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy -
Exclusion Criteria:polyposis syndrome, Inflammatory bowel disease, previous colorectal operation
-
About this study
Official title: 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.
- Conditions
- Serrated Polyp
- Being tested
- Carbon dioxide insufflation colonoscopy, Air insufflation colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide insufflation colonoscopyProcedure or surgery
Carbon dioxide insufflation colonoscopy
Air insufflation colonoscopyProcedure or surgery
Room air insufflation colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide insufflation colonoscopy | Experimental | Carbon dioxide insufflation colonoscopy Receives: Procedure: Carbon dioxide insufflation colonoscopy |
| Air insufflation colonoscopy | Active comparator | Room air insufflation colonoscopy Receives: Procedure: Air insufflation colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serrated polyp detection rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serrated PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Seon Ji, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623906
- Sponsor's protocol ID
- SDR
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation During Colonoscopy: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT03623906
- Acronym / sponsor ID
- SDR
- Conditions
- Serrated Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide insufflation colonoscopy | Experimental | Procedure: Carbon dioxide insufflation colonoscopyCarbon dioxide insufflation colonoscopy |
| Air insufflation colonoscopy | Active comparator | Procedure: Air insufflation colonoscopyRoom air insufflation colonoscopy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon dioxide insufflation colonoscopyCarbon dioxide insufflation colonoscopy | Procedure or surgery | Carbon dioxide insufflation colonoscopy |
| Air insufflation colonoscopyRoom air insufflation colonoscopy | Procedure or surgery | Air insufflation colonoscopy |
Primary outcome
Serrated polyp detection rate
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide insufflation colonoscopy and Air insufflation colonoscopy in people with Serrated Polyp, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serrated polyp detection rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.