PolypPhase 4NCT01124266
Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy
A Phase 4 study of Polyp and Adenomatous Polyp, run by Soon Chun Hyang University at 6 sites in South Korea.
Trial summary
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyp, Adenomatous Polyp, Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 6 sitesSouth Korea
- Study dates
- May 2010to Jan 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 50
- screening colonoscopy
Who cannot join
- History of colorectal surgery
- History of hereditary colorectal cancers or polyposis syndrome
- Gastrointestinal bleeding
- Inflammatory bowel diseases
- Inability to provide informed consent
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Dankook University Hospital
Cheonan
Soon Chun Hyang University Cheonan Hospital
Cheonan
Hanyang university Guri Hospital
Guri-si
The Catholic University Incheon St. Mary's Hospital
Incheon
Kangbuk Samsung Hospital
Seoul
Kyung Hee University Gangdong Hospital
Seoul
About this study
Official title: Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.
The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).
- Conditions
- Polyp, Adenomatous Polyp, Colonoscopy
- Being tested
- standard of care colonoscopy
- Keywords
- polyp, adenoma, screening, colonoscopy, diagnosis
- Medical subject headings
- Polyps, Adenomatous Polyps, Adenoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care colonoscopyProcedure or surgery
Single inspection by endoscopist during colonoscopy
standard of care colonoscopyProcedure or surgery
Dual inspection by both endoscopist and nurse during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| endoscopist only | Experimental | Not described Receives: Procedure: standard of care colonoscopy |
| nurse participation | Experimental | Not described Receives: Procedure: standard of care colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: 1 year
Secondary outcomes (7)
subjects with at least one polyp
Measured: 1 year
Subjects with at least one adenoma
Measured: 1 year
total number of polyp
Measured: 1 year
total number of adenoma
Measured: 1 year
Subjects with at least one advanced adenoma or cancer
Measured: 1 year
total number of advanced adenoma or cancer
Measured: 1 year
polyp and adenoma detection rate according to the endoscopists or nurse experience
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Hanyang University Guri Hospital, Dankook University, Incheon St.Mary's Hospital, Kyung Hee University Hospital at Gangdong
- Investigators
- Chang Kyun Lee, MD, PhD, Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124266
- Sponsor's protocol ID
- 2010-15
- Status last verified
- May 2010
- First submitted
- 14 May 2010
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27.
PubMed 18759826Peters SL, Hasan AG, Jacobson NB, Austin GL. Level of fellowship training increases adenoma detection rates. Clin Gastroenterol Hepatol. 2010 May;8(5):439-42. doi: 10.1016/j.cgh.2010.01.013. Epub 2010 Feb 1.
PubMed 20117245Lee CK, Park DI, Lee SH, Hwangbo Y, Eun CS, Han DS, Cha JM, Lee BI, Shin JE. Participation by experienced endoscopy nurses increases the detection rate of colon polyps during a screening colonoscopy: a multicenter, prospective, randomized study. Gastrointest Endosc. 2011 Nov;74(5):1094-102. doi: 10.1016/j.gie.2011.06.033. Epub 2011 Sep 1.
PubMed 21889137
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT01124266
- Acronym / sponsor ID
- 2010-15
- Conditions
- Polyp, Adenomatous Polyp, Colonoscopy
- Keywords
- polyp, adenoma, screening, colonoscopy, diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Hanyang University Guri Hospital, Dankook University, Incheon St.Mary's Hospital, Kyung Hee University Hospital at Gangdong
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 May 2010 (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.
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.
The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopist only | Experimental | Procedure: standard of care colonoscopy |
| nurse participation | Experimental | Procedure: standard of care colonoscopy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 50
- screening colonoscopy
Key exclusion criteria (6 listed)
- History of colorectal surgery
- History of hereditary colorectal cancers or polyposis syndrome
- Gastrointestinal bleeding
- Inflammatory bowel diseases
- Inability to provide informed consent
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 |
|---|---|---|
| standard of care colonoscopySingle inspection by endoscopist during colonoscopy | Procedure or surgery | endoscopist only |
| standard of care colonoscopyDual inspection by both endoscopist and nurse during colonoscopy | Procedure or surgery | nurse participation |
Primary outcome
adenoma detection rate
Time frame: 1 year
7 secondary outcomes
subjects with at least one polyp
Time frame: 1 year
Subjects with at least one adenoma
Time frame: 1 year
total number of polyp
Time frame: 1 year
total number of adenoma
Time frame: 1 year
Subjects with at least one advanced adenoma or cancer
Time frame: 1 year
total number of advanced adenoma or cancer
Time frame: 1 year
polyp and adenoma detection rate according to the endoscopists or nurse experience
Time frame: 1 year
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 17 Feb 2011.
- Background: PubMed 18759826Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27.
- Background: PubMed 20117245Peters SL, Hasan AG, Jacobson NB, Austin GL. Level of fellowship training increases adenoma detection rates. Clin Gastroenterol Hepatol. 2010 May;8(5):439-42. doi: 10.1016/j.cgh.2010.01.013. Epub 2010 Feb 1.
- Derived from this study: PubMed 21889137Lee CK, Park DI, Lee SH, Hwangbo Y, Eun CS, Han DS, Cha JM, Lee BI, Shin JE. Participation by experienced endoscopy nurses increases the detection rate of colon polyps during a screening colonoscopy: a multicenter, prospective, randomized study. Gastrointest Endosc. 2011 Nov;74(5):1094-102. doi: 10.1016/j.gie.2011.06.033. Epub 2011 Sep 1.
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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.
Chang Kyun Lee, MD, PhD principal investigator
Soon Chun Hyang University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Polyp and Adenomatous Polyp, run by Soon Chun Hyang University at 6 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 2 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: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 1 year). 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 NCT01124266, which also lists 3 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 17 Feb 2011.