Colonic PolypsNCT02693886
Effect of Single Colonoscopy on Colorectal Adenomas Detection
An observational study of Colonic Polyps, run by Wuxi People's Hospital.
Trial summary
Individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- doctor experience
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2017
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. greater than the age of 40; 2. Pathology and endoscopic data recorded available and detailed; 3. Whole bowel staining endoscopy is not done.
Who may be able to join
- Greater than the age of 40;
- Pathology and endoscopic data recorded available and detailed;
- Whole bowel staining endoscopy is not done.
Who cannot join
- Not reach the ileocecal junction;
- Colorectal cancer;
- Familial adenomatous polyposis;
- Inflammatory bowel disease;
- Part of the bowel resection.
About this study
Official title: Clinical Study That Effect of Individualized Intervention of Single Colonoscopy on Colorectal Adenomas Detection
Individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation.
- Conditions
- Colonic Polyps
- Being tested
- doctor experience
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doctor experienceOther
| Study group | Role | What they receive |
|---|---|---|
| A group | Experience of endoscopist: >2000 cases Receives: Other: doctor experience | |
| B group | Experience of endoscopist:between 1000 and 2000 cases Receives: Other: doctor experience | |
| C group | Experience of endoscopist:between 500 and 1000 cases Receives: Other: doctor experience | |
| D group | Experience of endoscopist:<500 cases Receives: Other: doctor experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of polyps in different withdraw time
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Detection rate of polyps in different experiment levels of examiners
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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.
- 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
- Case only
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693886
- Sponsor's protocol ID
- WX0302-B010507-150031-PB
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study That Effect of Individualized Intervention of Single Colonoscopy on Colorectal Adenomas Detection
- ClinicalTrials.gov ID
- NCT02693886
- Acronym / sponsor ID
- WX0302-B010507-150031-PB
- Conditions
- Colonic Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Feb 2016 (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.
Individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation.
Study design
- Observational model
- Case only
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A group | – | Other: doctor experienceExperience of endoscopist: >2000 cases |
| B group | – | Other: doctor experienceExperience of endoscopist:between 1000 and 2000 cases |
| C group | – | Other: doctor experienceExperience of endoscopist:between 500 and 1000 cases |
| D group | – | Other: doctor experienceExperience of endoscopist:<500 cases |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. greater than the age of 40; 2. Pathology and endoscopic data recorded available and detailed; 3. Whole bowel staining endoscopy is not done.
Key inclusion criteria (3 listed)
- Greater than the age of 40;
- Pathology and endoscopic data recorded available and detailed;
- Whole bowel staining endoscopy is not done.
Key exclusion criteria (5 listed)
- Not reach the ileocecal junction;
- Colorectal cancer;
- Familial adenomatous polyposis;
- Inflammatory bowel disease;
- Part of the bowel resection.
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 |
|---|---|---|
| doctor experience | Other | A group, B group, C group, D group |
Primary outcome
Detection rate of polyps in different withdraw time
Time frame: through study completion, an average of 1 year
1 secondary outcome
Detection rate of polyps in different experiment levels of examiners
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps, run by Wuxi People's Hospital.
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 3 inclusion and 5 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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Detection rate of polyps in different withdraw time (time frame: through study completion, an average of 1 year). 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 29 Feb 2016.