PolypNCT02292563
The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy
A study testing Colonoscopist only and Experienced Endoscopy Nurse Participation in people with Polyp and Adenoma, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Colonoscopist only and Experienced Endoscopy Nurse Participation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jul 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 40-70 average risk screening colonoscopy
Who cannot join
- GI Bleeding ;
- history of colorectal surgery ;
- inflammatory bowel disease ;
- colorectal cancer,or polyposis syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Experienced Endoscopy Nurse Participation During Screening Colonoscopy Increase Polyp and Adenoma Detection Rate?:A Prospective Randomized Trial
The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.
- Being tested
- Colonoscopist only, Experienced Endoscopy Nurse Participation
- Keywords
- Nurse; Colonoscopy; Polyp; Adenoma;
- Medical subject headings
- Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopist onlyProcedure or surgery
Only Colonosopist Observe during Colonoscopy (single observer)
Experienced Endoscopy Nurse ParticipationProcedure or surgery
Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)
| Study group | Role | What they receive |
|---|---|---|
| endoscopist only | Experimental | Single inspection by endoscopist during colonoscopy Receives: Procedure: Colonoscopist only; Procedure: Experienced Endoscopy Nurse Participation |
| nurse participation | Experimental | Dual inspection by both an endoscopist and an experienced nurse during colonoscopy Receives: Procedure: Colonoscopist only; Procedure: Experienced Endoscopy Nurse Participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection rate
Measured: 1.5 year
adenoma detection rate
Measured: 1.5 year
Secondary outcomes (1)
Advanced polyp detection rate
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionJul 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Xu, Ningbo No. 1 Hospital
- Investigators
- XIAOYUN DING, M.D, Study director, Ningbo No. 1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292563
- Sponsor's protocol ID
- NBYY2014001
- Status last verified
- Oct 2015
- First submitted
- 12 Nov 2014
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang W, Xu L, Bao Z, Sun L, Hu C, Zhou F, Xu L, Shi D. Differences with experienced nurse assistance during colonoscopy in detecting polyp and adenoma: a randomized clinical trial. Int J Colorectal Dis. 2018 May;33(5):561-566. doi: 10.1007/s00384-018-3003-0. Epub 2018 Mar 14.
PubMed 29541895
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Experienced Endoscopy Nurse Participation During Screening Colonoscopy Increase Polyp and Adenoma Detection Rate?:A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02292563
- Acronym / sponsor ID
- NBYY2014001
- Keywords
- Nurse; Colonoscopy; Polyp; Adenoma;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Nov 2014 (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 whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopist only | Experimental | Procedure: Colonoscopist only, Procedure: Experienced Endoscopy Nurse ParticipationSingle inspection by endoscopist during colonoscopy |
| nurse participation | Experimental | Procedure: Colonoscopist only, Procedure: Experienced Endoscopy Nurse ParticipationDual inspection by both an endoscopist and an experienced nurse during colonoscopy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 40-70 average risk screening colonoscopy
Key exclusion criteria (4 listed)
- GI Bleeding ;
- history of colorectal surgery ;
- inflammatory bowel disease ;
- colorectal cancer,or polyposis syndrome
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 |
|---|---|---|
| Colonoscopist onlyOnly Colonosopist Observe during Colonoscopy (single observer) | Procedure or surgery | endoscopist only, nurse participation |
| Experienced Endoscopy Nurse ParticipationExperienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe) | Procedure or surgery | endoscopist only, nurse participation |
Primary outcome
Polyp detection rate
Time frame: 1.5 year
adenoma detection rate
Time frame: 1.5 year
1 secondary outcome
Advanced polyp detection rate
Time frame: 1.5 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 2 Jul 2019.
- Derived from this study: PubMed 29541895Wang W, Xu L, Bao Z, Sun L, Hu C, Zhou F, Xu L, Shi D. Differences with experienced nurse assistance during colonoscopy in detecting polyp and adenoma: a randomized clinical trial. Int J Colorectal Dis. 2018 May;33(5):561-566. doi: 10.1007/s00384-018-3003-0. Epub 2018 Mar 14.
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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.
XIAOYUN DING, M.D study director
Ningbo No. 1 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 Colonoscopist only and Experienced Endoscopy Nurse Participation in people with Polyp and Adenoma, run by Ningbo No. 1 Hospital at 1 site in China.
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 4 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 2 Jul 2019. 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 China. 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?
Polyp detection rate (time frame: 1.5 year). The study lists 2 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 NCT02292563, 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 2 Jul 2019.