ColonoscopyNCT03796169
Effect of Intervention for Colonoscopy Quality is Associated With the Personal Characteristics
A study testing Personal notification, Open notification and Education in people with Colonoscopy and Human Characteristics, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement. This is a prospective, 9-month, multicenter, single-blind study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Human Characteristics
- What is being tested?
- Personal notification, Open notification and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2018to 12 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Highly experienced board-certified gastroenterologists performed colonoscopies in health screening endoscopy centers.
- Endoscopists who sign the consent
- Patients for quality indicators of endoscopists
- routinely perform outpatient screening, surveillance and diagnostic colonoscopy (first-time screening colonoscopies performed and had no previous colonoscopy within 3 years).
Who cannot join
- endoscopists who refuse to sign the consent
- Patients for quality indicators of endoscopists
- Known hereditary polyposis syndrome, Inflammatory bowel disease, those with surgically altered anatomy, undergone previous colonoscopy within 3 years
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology; Seoul St. Mary's hospital
Seoul, 137-701
About this study
Official title: Effect of Intervention for Improving Colonoscopy Quality is Associated With the Personal Characteristics of the Endoscopist
This study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement.
This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per colonoscopy of each endoscopist were measured in the health promotion centers of academic hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3 months after each interventions (personal notification of quality indicators, open notification of quality indicators, and colonoscopy quality education by a GI faculty. At the end of the study, personal characteristics of each endoscopist was evaluated using fear of negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.
Read the detailed description
Suboptimal colonoscopy quality is associated with development of interval colorectal cancer and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality effectively. The quality of screening colonoscopy for colorectal cancer depends on the endoscopist who performed the examination. The aim of this study was to investigate the impact of endoscopists' personal characteristics on the quality of colonoscopy and effectiveness of intervention.
- Conditions
- Colonoscopy, Human Characteristics
- Being tested
- Personal notification, Open notification, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal notificationBehavioural
Baseline quality indicators of each endoscopist were measured and those were notified individually.
Open notificationBehavioural
Quality indicators were measured for 3 months after 1st interventions and those were notified openly
EducationBehavioural
Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty
| Study group | Role | What they receive |
|---|---|---|
| Endoscopist | Experimental | Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty Receives: Behavioral: Personal notification; Behavioral: Open notification; Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of overall adenoma detection rate
Primary outcome measures include overall adenoma detection rate.
Measured: 9 months
Measurement of adenoma detection rate after personal notification
Primary outcome measures include adenoma detection rate after personal notification
Measured: 3 months after personal notification
Measurement of adenoma detection rate after open notification
Primary outcome measures include adenoma detection rate after open notification
Measured: 3 months after open notification
Measurement of adenoma detection rate after education
Primary outcome measures include adenoma detection rate after education
Measured: 3 months after education
Secondary outcomes (12)
Measurement of overall polyp detection rate
Secondary outcome measures include overall polyp detection rate.
Measured: 9 months
Measurement of overall withdrawal time
Secondary outcome measures include overall withdrawal time.
Measured: 9 months
Measurement of overall adenomas per colonoscopy
Secondary outcome measures include overall adenomas per colonoscopy.
Measured: 9 months
Measurement of polyp detection rate after personal notification
Primary outcome measures include polyp detection rate after personal notification
Measured: 3 months after personal notification
Measurement of polyp detection rate after open notification
Primary outcome measures include polyp detection rate after open notification
Measured: 3 months after open notification
Measurement of polyp detection rate after education
Primary outcome measures include polyp detection rate after education
Measured: 3 months after education
Measurement of withdrawal time after personal notification
Primary outcome measures include withdrawal time after personal notification
Measured: 3 months after personal notification
Measurement of withdrawal time after open notification
Primary outcome measures include withdrawal time after open notification
Measured: 3 months after open notification
Measurement of withdrawal time after education
Primary outcome measures include withdrawal time after education
Measured: 3 months after education
Measurement of adenomas per colonoscopy after personal notification
Primary outcome measures include adenomas per colonoscopy after personal notification.
Measured: 3 months after personal notification
Measurement of adenomas per colonoscopy after open notification
Primary outcome measures include adenomas per colonoscopy after open notification
Measured: 3 months after open notification
Measurement of adenomas per colonoscopy after education
Primary outcome measures include adenoma detection rate after education
Measured: 3 months after education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start12 Dec 2018
- Primary completion12 Dec 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Vincent's Hospital, Korea, Uijeongbu St. Mary Hospital
- Responsible party
- Principal investigator, Bo-In Lee, Seoul St. Mary's Hospital
- Investigators
- Bo-In Lee, MD, PhD, Principal investigator, Division of Gastroenterology; Seoul St. Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796169
- Sponsor's protocol ID
- XC15FIMI0020K
- Status last verified
- Sep 2020
- First submitted
- 16 Dec 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8.
PubMed 23295274Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7.
PubMed 19665583Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4.
PubMed 26845473Choi HH, Sung SY, Lee BI, Cho H, Jung Y, Park JM, Cho YS, Lee KM, Kim SW, Choi H, Chae HS, Choi MG. The Effect of Intervention for Improving Colonoscopy Quality Is Associated with the Personality Traits of Endoscopists. Gut Liver. 2024 Mar 15;18(2):265-274. doi: 10.5009/gnl220280. Epub 2023 May 9.
PubMed 37158042
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intervention for Improving Colonoscopy Quality is Associated With the Personal Characteristics of the Endoscopist
- ClinicalTrials.gov ID
- NCT03796169
- Acronym / sponsor ID
- XC15FIMI0020K
- Conditions
- Colonoscopy, Human Characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Saint Vincent's Hospital, Korea, Uijeongbu St. Mary Hospital
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 8 Jan 2019 (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.
This study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement.
This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per colonoscopy of each endoscopist were measured in the health promotion centers of academic hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3 months after each interventions (personal notification of quality indicators, open notification of quality indicators, and colonoscopy quality education by a GI faculty. At the end of the study, personal characteristics of each endoscopist was evaluated using fear of negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.
Detailed description
Suboptimal colonoscopy quality is associated with development of interval colorectal cancer and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality effectively. The quality of screening colonoscopy for colorectal cancer depends on the endoscopist who performed the examination. The aim of this study was to investigate the impact of endoscopists' personal characteristics on the quality of colonoscopy and effectiveness of intervention.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopist | Experimental | Behavioral: Personal notification, Behavioral: Open notification, Behavioral: EducationIntervention for personal notification, open notification and colonoscopy quality education by a GI faculty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Highly experienced board-certified gastroenterologists performed colonoscopies in health screening endoscopy centers.
- Endoscopists who sign the consent
- Patients for quality indicators of endoscopists
Key exclusion criteria (3 listed)
- endoscopists who refuse to sign the consent
- Patients for quality indicators of endoscopists
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 |
|---|---|---|
| Personal notificationBaseline quality indicators of each endoscopist were measured and those were notified individually. | Behavioural | Endoscopist |
| Open notificationQuality indicators were measured for 3 months after 1st interventions and those were notified openly | Behavioural | Endoscopist |
| EducationQuality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty | Behavioural | Endoscopist |
Primary outcome
Measurement of overall adenoma detection rate
Time frame: 9 months
Primary outcome measures include overall adenoma detection rate.
Measurement of adenoma detection rate after personal notification
Time frame: 3 months after personal notification
Primary outcome measures include adenoma detection rate after personal notification
Measurement of adenoma detection rate after open notification
Time frame: 3 months after open notification
Primary outcome measures include adenoma detection rate after open notification
Measurement of adenoma detection rate after education
Time frame: 3 months after education
Primary outcome measures include adenoma detection rate after education
12 secondary outcomes
Measurement of overall polyp detection rate
Time frame: 9 months
Measurement of overall withdrawal time
Time frame: 9 months
Measurement of overall adenomas per colonoscopy
Time frame: 9 months
Measurement of polyp detection rate after personal notification
Time frame: 3 months after personal notification
Measurement of polyp detection rate after open notification
Time frame: 3 months after open notification
Measurement of polyp detection rate after education
Time frame: 3 months after education
Measurement of withdrawal time after personal notification
Time frame: 3 months after personal notification
Measurement of withdrawal time after open notification
Time frame: 3 months after open notification
Measurement of withdrawal time after education
Time frame: 3 months after education
Measurement of adenomas per colonoscopy after personal notification
Time frame: 3 months after personal notification
Measurement of adenomas per colonoscopy after open notification
Time frame: 3 months after open notification
Measurement of adenomas per colonoscopy after education
Time frame: 3 months after education
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 9 Sep 2020.
- Background: PubMed 23295274Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8.
- Background: PubMed 19665583Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7.
- Background: PubMed 26845473Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4.
- Derived from this study: PubMed 37158042Choi HH, Sung SY, Lee BI, Cho H, Jung Y, Park JM, Cho YS, Lee KM, Kim SW, Choi H, Chae HS, Choi MG. The Effect of Intervention for Improving Colonoscopy Quality Is Associated with the Personality Traits of Endoscopists. Gut Liver. 2024 Mar 15;18(2):265-274. doi: 10.5009/gnl220280. Epub 2023 May 9.
- 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.
Bo-In Lee, MD, PhD principal investigator
Division of Gastroenterology; Seoul St. Mary's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal notification, Open notification and Education in people with Colonoscopy and Human Characteristics, run by Seoul St. Mary's Hospital 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 4 inclusion and 3 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 9 Sep 2020. 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?
Measurement of overall adenoma detection rate (time frame: 9 months). The study lists 4 primary outcomes in all. 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 NCT03796169, which also lists 4 linked publications.
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 Sep 2020.