Adenoma Detection RateNCT04397120
The Factors Affecting ADR of Screening Colonoscopy
An observational study of Adenoma Detection Rate and Colonoscopy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenoma Detection Rate, Colonoscopy
- How many people
- 13,495 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Endoscopy Department of a university Hospital
Who may be able to join
- Patients were retrospectively included in this study if they had undergone a completed colonoscopy.
Who cannot join
- prior colonoscopy within 3 years;
- medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;
- fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but >90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with <90% of mucosal surface seen);
- failure in cecal intubation;
- withdrawal time without removing<6 min.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
About this study
Official title: Comprehensive Analysis of Multilevel Factors Affecting Adenoma Detection Rates of Screening Colonoscopy
The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).
Read the detailed description
The subjects will include patients who need to screening colonoscopies by 21 endoscopists between January 2019 and December 2019 were retrospectively enrolled in this unit. Multilevel factors, including patient-, proceduralist-, and procedure-level characteristics were analyzed for the relationship with ADR.
- Conditions
- Adenoma Detection Rate, Colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
the proportion of colonoscopies in which at least one adenoma was detected
Measured: After histopathologically examined, reviewed, and confirmed, an average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma Detection RateStudies 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
- Time perspective
- Retrospective
- Enrolment
- 13,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Lu, M.D., Principal investigator, First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397120
- Sponsor's protocol ID
- CADR-HuY-2005
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing will be consider after study
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis of Multilevel Factors Affecting Adenoma Detection Rates of Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT04397120
- Acronym / sponsor ID
- CADR-HuY-2005
- Conditions
- Adenoma Detection Rate, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,495 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 21 May 2020 (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.
The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).
Detailed description
The subjects will include patients who need to screening colonoscopies by 21 endoscopists between January 2019 and December 2019 were retrospectively enrolled in this unit. Multilevel factors, including patient-, proceduralist-, and procedure-level characteristics were analyzed for the relationship with ADR.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Endoscopy Department of a university Hospital
Key inclusion criteria (1 listed)
- Patients were retrospectively included in this study if they had undergone a completed colonoscopy.
Key exclusion criteria (5 listed)
- prior colonoscopy within 3 years;
- medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;
- fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but >90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with <90% of mucosal surface seen);
- failure in cecal intubation;
- withdrawal time without removing<6 min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adenoma detection rate
Time frame: After histopathologically examined, reviewed, and confirmed, an average of 7 days.
the proportion of colonoscopies in which at least one adenoma was detected
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 21 May 2020.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing will be consider after study
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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.
Bin Lu, M.D. principal investigator
First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma Detection Rate and Colonoscopy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University 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 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: finished, as of the sponsor's last update on 21 May 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 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?
Adenoma detection rate (time frame: After histopathologically examined, reviewed, and confirmed, an average of 7 days.). 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 21 May 2020.