Adenoma of Large IntestineNCT01925833
Adenoma Detection by Polypectomy During Both Insertion and Withdrawal
A study testing Both insertion and withdrawal and Only withdrawal in people with Adenoma of Large Intestine, run by The Catholic University of Korea.
Trial summary
Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. <1cm) seen during insertion phase are difficult to find during withdrawal phase. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Adenoma of Large Intestine
- What is being tested?
- Both insertion and withdrawal and Only withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,142 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2016
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing screening or surveillance colonoscopy
Who cannot join
- Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease
About this study
Official title: Comparison of Adenoma Detection by Polypectomy During Both Insertion and Withdrawal Versus Only Withdrawal of Colonoscopy: a Randomized, Controlled Trial
Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.
- Conditions
- Adenoma of Large Intestine
- Being tested
- Both insertion and withdrawal, Only withdrawal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Both insertion and withdrawalProcedure or surgery
inspection and polypectomy during both insertion and withdrawal of colonoscopy
Only withdrawalProcedure or surgery
inspection and polypectomy during only withdrawal of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Both insertion and withdrawal | Experimental | Not described Receives: Procedure: Both insertion and withdrawal |
| Only withdrawal | Active comparator | Not described Receives: Procedure: Only withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: 4 weeks
Secondary outcomes (1)
Number of adenoma per patient
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma of Large IntestineStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,142 participants (actual)
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
- NCT01925833
- Sponsor's protocol ID
- Insertion
- Status last verified
- Feb 2019
- First submitted
- 16 Aug 2013
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gweon TG, Lee SW, Ji JS, Lee JR, Kim JS, Kim BW, Choi H. Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial. Surg Endosc. 2020 Dec;34(12):5461-5468. doi: 10.1007/s00464-019-07342-4. Epub 2020 Jan 17.
PubMed 31953727
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adenoma Detection by Polypectomy During Both Insertion and Withdrawal Versus Only Withdrawal of Colonoscopy: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01925833
- Acronym / sponsor ID
- Insertion
- Conditions
- Adenoma of Large Intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,142 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Both insertion and withdrawal | Experimental | Procedure: Both insertion and withdrawal |
| Only withdrawal | Active comparator | Procedure: Only withdrawal |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing screening or surveillance colonoscopy
Key exclusion criteria (1 listed)
- Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease
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 |
|---|---|---|
| Both insertion and withdrawalinspection and polypectomy during both insertion and withdrawal of colonoscopy | Procedure or surgery | Both insertion and withdrawal |
| Only withdrawalinspection and polypectomy during only withdrawal of colonoscopy | Procedure or surgery | Only withdrawal |
Primary outcome
Adenoma detection rate
Time frame: 4 weeks
1 secondary outcome
Number of adenoma per patient
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 31953727Gweon TG, Lee SW, Ji JS, Lee JR, Kim JS, Kim BW, Choi H. Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial. Surg Endosc. 2020 Dec;34(12):5461-5468. doi: 10.1007/s00464-019-07342-4. Epub 2020 Jan 17.
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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 Both insertion and withdrawal and Only withdrawal in people with Adenoma of Large Intestine, 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adenoma detection rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01925833, which also lists 1 linked publication.
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 12 Feb 2019.