Colonic PolypsNCT02385552
Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist
An observational study of Colonic Polyps and Colonic Neoplasms, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to determine clinical factors affecting quality indicators of colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be elevated by improving related factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps, Colonic Neoplasms
- What is being tested?
- Feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Mar 2011to Dec 2019
- How long will I take part?
- 8 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.
Who may be able to join
- Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.
Who cannot join
- Age <18 years
- Customers who refused to offer their health check up data
- History of inflammatory bowel disease
- History of familial adenomatous polyposis
- Customers who received Incomplete colonoscopy
- History of previous colorectal resection
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Healthcare System Gangnam Center, Seoul National University Hospital
Seoul
Ji Yeon Seo, M.D., 82-2-2112-5641, sjy@snuh.org
Changhyun Lee, M.D., 82-2-2112-5578, mdchlee@snuh.org
- Recruiting
Ji Yeon Seo
Seoul
Ji Yeon Seo, M.D., 82-2-2112-5641, sjy@snuh.org
Changhyun Lee, M.D., 82-2-2112-5578, mdchlee@snuh.org
About this study
Official title: Seoul National University Hospital Healthcare System Gangnam Center Colonoscopy Quality Upgrade Project (Gangnam-CUP): Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist.
The purpose of this study is to determine clinical factors affecting quality indicators of colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be elevated by improving related factors.
Read the detailed description
This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of five periods. First, quality indicators of colonoscopy in experienced endoscopists will be analyzed retrospectively from January 2011 to december 2014. Individual differences and changes of quality indicators in every endoscopist will be verified. In second period, from January 2015 to March 2015, quality assurance program will be activated. Endoscopists will be educated by EQUIP (Endoscopic Quality Improvement Program). Also split-regimen bowel preparation instead of same-day regimen and Boston bowel preparation scale will be introduced to standardize disparity of grading. Third, prospective trial starts from April 2015 to March 2018. All endoscopists will receive feedbacks of their own adenoma detection rates in every 3 months. Changes of quality indicators for each endoscopist will be investigated, and annually monitored by institutional review board. If there is a significant improvement of quality indicators in interim assessment, prospective trial will be extended until April 2018. Fourth is wash-out period from April 2018 to march 2019. Feedbacks will be stopped and adenoma detection rates and quality indicators of endoscopists will be compared with those from prospective period. Finally, cumulative rate and mortality rate of colorectal cancers will be investigated until December 2019.
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Being tested
- Feedback
- Keywords
- colonoscopy, quality improvement, adenoma detection rate
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackBehavioural
Experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates.
| Study group | Role | What they receive |
|---|---|---|
| Experienced endoscopists | All of the experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rate every 3 months Receives: Behavioral: Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
(total, right, transverse, left)
Measured: 8 years
Secondary outcomes (10)
Colonoscopy performance indicators
Colonoscopy withdrawal time in negative complete colonoscopy
Measured: 8 years
Colonoscopy performance indicators
The number of taken pictures in negative complete colonoscopy
Measured: 8 years
Colonoscopy performance indicators
The position changes during colonoscope insertion and withdrawal
Measured: 8 years
Colonoscopy quality indicators
Colorectal cancer detection rate
Measured: 8 years
Colonoscopy quality indicators
Advanced adenoma detection rate
Measured: 8 years
Colonoscopy quality indicators
Adenoma detection rate plus
Measured: 8 years
Colonoscopy quality indicators
Polyp detection rate (total, right, transverse, left)
Measured: 8 years
Colonoscopy quality indicators
Multiple adenoma detection rate
Measured: 8 years
Colonoscopy quality indicators
Serrated polyp detection rate (total, right, transverse, left)
Measured: 8 years
Colonoscopy quality indicators
Complication rate (bleeding, perforation, pain)
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2011
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Chung, Seoul National University Hospital
- Investigators
- Su Jin Chung, M.D., Ph.D., Principal investigator, Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385552
- Sponsor's protocol ID
- H-1502-003-644
- Status last verified
- Apr 2016
- First submitted
- 1 Mar 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seoul National University Hospital Healthcare System Gangnam Center Colonoscopy Quality Upgrade Project (Gangnam-CUP): Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist.
- ClinicalTrials.gov ID
- NCT02385552
- Acronym / sponsor ID
- H-1502-003-644
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Keywords
- colonoscopy, quality improvement, adenoma detection rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Mar 2015 (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.
The purpose of this study is to determine clinical factors affecting quality indicators of colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be elevated by improving related factors.
Detailed description
This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of five periods. First, quality indicators of colonoscopy in experienced endoscopists will be analyzed retrospectively from January 2011 to december 2014. Individual differences and changes of quality indicators in every endoscopist will be verified. In second period, from January 2015 to March 2015, quality assurance program will be activated. Endoscopists will be educated by EQUIP (Endoscopic Quality Improvement Program). Also split-regimen bowel preparation instead of same-day regimen and Boston bowel preparation scale will be introduced to standardize disparity of grading. Third, prospective trial starts from April 2015 to March 2018. All endoscopists will receive feedbacks of their own adenoma detection rates in every 3 months. Changes of quality indicators for each endoscopist will be investigated, and annually monitored by institutional review board. If there is a significant improvement of quality indicators in interim assessment, prospective trial will be extended until April 2018. Fourth is wash-out period from April 2018 to march 2019. Feedbacks will be stopped and adenoma detection rates and quality indicators of endoscopists will be compared with those from prospective period. Finally, cumulative rate and mortality rate of colorectal cancers will be investigated until December 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced endoscopists | – | Behavioral: FeedbackAll of the experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rate every 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.
Key inclusion criteria (1 listed)
- Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.
Key exclusion criteria (6 listed)
- Age <18 years
- Customers who refused to offer their health check up data
- History of inflammatory bowel disease
- History of familial adenomatous polyposis
- Customers who received Incomplete colonoscopy
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 |
|---|---|---|
| FeedbackExperienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates. | Behavioural | Experienced endoscopists |
Primary outcome
Adenoma detection rate
Time frame: 8 years
(total, right, transverse, left)
10 secondary outcomes
Colonoscopy performance indicators
Time frame: 8 years
Colonoscopy performance indicators
Time frame: 8 years
Colonoscopy performance indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Colonoscopy quality indicators
Time frame: 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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.
Su Jin Chung, M.D., Ph.D. principal investigator
Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps and Colonic Neoplasms, run by Seoul National University Hospital at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Yeon Seo, M.D. (82-2-2112-5641, sjy@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 8 years). 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 18 Apr 2016.