Adenoma Detection RateTraCoNCT01786213
Training Effects in Colonoscopy
An observational study of Adenoma Detection Rate, run by Technical University of Munich at 1 site in Germany.
Trial summary
Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma Detection Rate
- How many people
- 3,500 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Jan 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Endoscopy Department of a university Hospital
Who may be able to join
- colonoscopy performed at the Technical University Munich, Germany
Who cannot join
- colonoscopy performed for the purpose of polypectomy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik und Poliklinik der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: The Impact of Training Effects on Quality Indicators in Colonoscopy: a Retrospective Study.
Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a multitude of circumstances such as bowel cleanness. The facts that detection rates vary between colonoscopists suggests that leaning effects may also play a role. It is not known how ADR and other quality parameters evolve while trainees improve their skills in colonoscopy. The investigators postulate that a learning curve exists. The investigators therefore plan to evaluate chronologically the findings of trainee colonoscopists. A particular performance in detecting adenomas shall be calculated in relation to the amount of examinations performed.
- Conditions
- Adenoma Detection Rate
- Keywords
- adenoma detection rate, colonoscopy, trainee, learning curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopist A | Not described | |
| Colonoscopist B | Not described | |
| Colonoscopist C | Not described | |
| Colonoscopist D | Not described | |
| Colonoscopist E | Not described | |
| Colonoscopist F | Not described | |
| Colonoscopist G | Not described | |
| Colonoscopist H | Not described | |
| Colonoscopist I | Not described | |
| Colonoscopist J | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
While numbers of investigations rise new detection rates are calculated for each colonoscopist.
Measured: every 50 examinations
Secondary outcomes (1)
Polyp detection rate
Measured: every 50 examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJan 2014
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
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786213
- Sponsor's protocol ID
- TraCo
- Acronym
- TraCo
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Training Effects on Quality Indicators in Colonoscopy: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT01786213
- Acronym / sponsor ID
- TraCo / TraCo
- Conditions
- Adenoma Detection Rate
- Keywords
- adenoma detection rate, colonoscopy, trainee, learning curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Feb 2013 (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.
Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a multitude of circumstances such as bowel cleanness. The facts that detection rates vary between colonoscopists suggests that leaning effects may also play a role. It is not known how ADR and other quality parameters evolve while trainees improve their skills in colonoscopy. The investigators postulate that a learning curve exists. The investigators therefore plan to evaluate chronologically the findings of trainee colonoscopists. A particular performance in detecting adenomas shall be calculated in relation to the amount of examinations performed.
Study design
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Colonoscopist A | – | – |
| Colonoscopist B | – | – |
| Colonoscopist C | – | – |
| Colonoscopist D | – | – |
| Colonoscopist E | – | – |
| Colonoscopist F | – | – |
| Colonoscopist G | – | – |
| Colonoscopist H | – | – |
| Colonoscopist I | – | – |
| Colonoscopist J | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Endoscopy Department of a university Hospital
Key inclusion criteria (1 listed)
- colonoscopy performed at the Technical University Munich, Germany
Key exclusion criteria (1 listed)
- colonoscopy performed for the purpose of polypectomy
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: every 50 examinations
While numbers of investigations rise new detection rates are calculated for each colonoscopist.
1 secondary outcome
Polyp detection rate
Time frame: every 50 examinations
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 6 Feb 2014.
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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.
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, run by Technical University of Munich at 1 site in Germany.
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 1 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 6 Feb 2014. 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 Germany. 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: every 50 examinations). 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 6 Feb 2014.