Harm ReductionNCT02425657
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
An observational study of Harm Reduction and Perforation During Colonoscopy, run by Aalborg University Hospital at 3 sites in Denmark.
Trial summary
Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al. The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Harm Reduction, Perforation During Colonoscopy, Colorectal Cancer
- What is being tested?
- Training of junior doctors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 3 sitesDenmark
- Study dates
- 14 Sep 2016to 1 Jul 2021
- 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: Junior doctors in North Jutland Surgical Departments defined as PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.
Who may be able to join
- Doctors currently enrolled in PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.
- Able to arrange colonoscopy training in such a way that the total program can be completed in 12 weeks.
- Able to perform supervised upper endoscopy.
Who cannot join
- Less than 4 months left at current job position.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 3 recruiting
- Recruiting
NordSim, Aalborg University Hospital
Aalborg, 9000
Lasse L Pedersen, m.d., +4597661212, lasse.pedersen@rn.dk
Inge Bernstein, PhD, MHM
- Recruiting
Hjörring Hospial
Hjørring, 9800
Lasse Pedersen, m.d., +45 97661212, lasse.pedersen@rn.dk
- Recruiting
Aalborg University Hospital:Hobro
Hobro, Jutland, 9500
Lasse Pedersen, m.d., +45 97661212, lasse.pedersen@rn.dk
About this study
Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al.
The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .
Read the detailed description
Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.
The training program for junior doctors consist of the following:
- Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.
- 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room
- MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.
- Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,
- Being tested
- Training of junior doctors
- Keywords
- Education, Training, Fast track, Colonoscopy
- Medical subject headings
- Harm Reduction, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of junior doctorsBehavioural
Training program
| Study group | Role | What they receive |
|---|---|---|
| Junior Doctors | Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2). Receives: Behavioral: Training of junior doctors |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCSAT (Mayo Clinical Skills Assessment Tool)
Measured at day 0,5,10,15 and 20.
Measured: 12 weeks
Secondary outcomes (5)
Endoscopy training computer generated data - Percentage of colon visualized
Computer generated score (Simulator test performed at day 0, 10 and 20)
Measured: 12 weeks
Endoscopy training computer generated data - Time to cecum
Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)
Measured: 12 weeks
Endoscopy training computer generated data - Estimated patient pain
Computer generated score (Simulator test performed at day 0, 10 and 20)
Measured: 12 weeks
Endoscopy training computer generated data: Percentage spent with clear view
Computer generated score (Simulator test performed at day 0, 10 and 20)
Measured: 12 weeks
Endoscopy training computer generated data - Total score
Computer generated score (Simulator test performed at day 0, 10 and 20)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start14 Sep 2016
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Harm ReductionStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsim
- Responsible party
- Principal investigator, Lasse Pedersen, Aalborg University Hospital
- Investigators
- Lasse Pedersen, m.d., Principal investigator, Aaborg University Surgical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425657
- Sponsor's protocol ID
- AalborgH1
- Status last verified
- Jul 2019
- First submitted
- 10 Apr 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fried GM, Marks JM, Mellinger JD, Trus TL, Vassiliou MC, Dunkin BJ. ASGE's assessment of competency in endoscopy evaluation tools for colonoscopy and EGD. Gastrointest Endosc. 2014 Aug;80(2):366-7. doi: 10.1016/j.gie.2014.03.019. No abstract available.
PubMed 25034851Preisler L, Svendsen MBS, Nerup N, Svendsen LB, Konge L. Simulation-based training for colonoscopy: establishing criteria for competency. Medicine (Baltimore). 2015 Jan;94(4):e440. doi: 10.1097/MD.0000000000000440.
PubMed 25634177Sedlack RE. Training to competency in colonoscopy: assessing and defining competency standards. Gastrointest Endosc. 2011 Aug;74(2):355-366.e1-2. doi: 10.1016/j.gie.2011.02.019. Epub 2011 Apr 23.
PubMed 21514931Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.
PubMed 25670810
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
- ClinicalTrials.gov ID
- NCT02425657
- Acronym / sponsor ID
- AalborgH1
- Keywords
- Education, Training, Fast track, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Nordsim
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 24 Apr 2015 (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.
Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al.
The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .
Detailed description
Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.
The training program for junior doctors consist of the following:
- Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.
- 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room
- MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.
- Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Junior Doctors | – | Behavioral: Training of junior doctorsSurgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Junior doctors in North Jutland Surgical Departments defined as PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.
Key inclusion criteria (3 listed)
- Doctors currently enrolled in PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.
- Able to arrange colonoscopy training in such a way that the total program can be completed in 12 weeks.
- Able to perform supervised upper endoscopy.
Key exclusion criteria (1 listed)
- Less than 4 months left at current job position.
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 |
|---|---|---|
| Training of junior doctorsTraining program | Behavioural | Junior Doctors |
Primary outcome
MCSAT (Mayo Clinical Skills Assessment Tool)
Time frame: 12 weeks
Measured at day 0,5,10,15 and 20.
5 secondary outcomes
Endoscopy training computer generated data - Percentage of colon visualized
Time frame: 12 weeks
Endoscopy training computer generated data - Time to cecum
Time frame: 12 weeks
Endoscopy training computer generated data - Estimated patient pain
Time frame: 12 weeks
Endoscopy training computer generated data: Percentage spent with clear view
Time frame: 12 weeks
Endoscopy training computer generated data - Total score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 25034851Fried GM, Marks JM, Mellinger JD, Trus TL, Vassiliou MC, Dunkin BJ. ASGE's assessment of competency in endoscopy evaluation tools for colonoscopy and EGD. Gastrointest Endosc. 2014 Aug;80(2):366-7. doi: 10.1016/j.gie.2014.03.019. No abstract available.
- Background: PubMed 25634177Preisler L, Svendsen MBS, Nerup N, Svendsen LB, Konge L. Simulation-based training for colonoscopy: establishing criteria for competency. Medicine (Baltimore). 2015 Jan;94(4):e440. doi: 10.1097/MD.0000000000000440.
- Background: PubMed 21514931Sedlack RE. Training to competency in colonoscopy: assessing and defining competency standards. Gastrointest Endosc. 2011 Aug;74(2):355-366.e1-2. doi: 10.1016/j.gie.2011.02.019. Epub 2011 Apr 23.
- Background: PubMed 25670810Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.
- Individual participant dataSharing planned: No
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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.
Lasse Pedersen, m.d. principal investigator
Aaborg University Surgical Department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Harm Reduction and Perforation During Colonoscopy, run by Aalborg University Hospital at 3 sites in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 5 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 3 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lasse Pedersen, m.d. ((+45) 97661212, lasse.pedersen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCSAT (Mayo Clinical Skills Assessment Tool) (time frame: 12 weeks). 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 NCT02425657, which also lists 4 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 5 Jul 2019.