AdenomaNCT03268200
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
A study testing segmental reexamination in people with Adenoma, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma
- What is being tested?
- segmental reexamination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy
Who cannot join
- Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
- If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Incheon St. Mary's hospital, Catholic university of Korea
Incheon, 403-720
About this study
Official title: The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial
The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach.
Read the detailed description
The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent. In addition, if the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
A randomization list was generated with the randomization algorithm of random sorting, using Excel program. Included patients were randomly assigned to one of the two groups: segmental re-examination group, in which the each segment (right colon, mid-colon, and left colon) was examined twice segmentally; or control group, in which the withdrawal time in the each segment was about 2 minutes.
- Conditions
- Adenoma
- Being tested
- segmental reexamination
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental reexaminationOther
segmental reexamination during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Each segment of colon (right colon, mid-colon, and left colon) was examined twice Receives: Other: segmental reexamination |
| Control group | No intervention | Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: 7 days
Secondary outcomes (3)
Per-patient adenoma detection rate (ADR) at each segment of colon
Measured: 7 days
per-patient polyp detection rate
Measured: 7 days
Withdrawal time
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
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 AdenomaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 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
- NCT03268200
- Sponsor's protocol ID
- reexamination
- Status last verified
- Jul 2023
- First submitted
- 29 Aug 2017
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee DS, Ji JS, Gweon TG, Seo M, Choi H. Efficacy of colonoscopic re-examination across the entire colon: a randomized controlled trial. Surg Endosc. 2024 Nov;38(11):6711-6717. doi: 10.1007/s00464-024-11298-5. Epub 2024 Sep 26.
PubMed 39327294
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03268200
- Acronym / sponsor ID
- reexamination
- Conditions
- Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Aug 2017 (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.
The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach.
Detailed description
The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent. In addition, if the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
A randomization list was generated with the randomization algorithm of random sorting, using Excel program. Included patients were randomly assigned to one of the two groups: segmental re-examination group, in which the each segment (right colon, mid-colon, and left colon) was examined twice segmentally; or control group, in which the withdrawal time in the each segment was about 2 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Other: segmental reexaminationEach segment of colon (right colon, mid-colon, and left colon) was examined twice |
| Control group | No intervention | –Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy
Key exclusion criteria (2 listed)
- Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
- If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
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 |
|---|---|---|
| segmental reexaminationsegmental reexamination during colonoscopy | Other | Case group |
Primary outcome
Adenoma detection rate
Time frame: 7 days
3 secondary outcomes
Per-patient adenoma detection rate (ADR) at each segment of colon
Time frame: 7 days
per-patient polyp detection rate
Time frame: 7 days
Withdrawal time
Time frame: 1 days
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 27 Jul 2023.
- Derived from this study: PubMed 39327294Lee DS, Ji JS, Gweon TG, Seo M, Choi H. Efficacy of colonoscopic re-examination across the entire colon: a randomized controlled trial. Surg Endosc. 2024 Nov;38(11):6711-6717. doi: 10.1007/s00464-024-11298-5. Epub 2024 Sep 26.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing segmental reexamination in people with Adenoma, run by The Catholic University of Korea at 1 site in South 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 2 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 7 days). 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 NCT03268200, 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 27 Jul 2023.