Clinical trial NCT02425657: Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
Official title: Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Harm Reduction
Perforation During Colonoscopy
Colorectal Cancer
Keywords: Education
Training
Fast track
Colonoscopy
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Nordsim
First posted: 2015-04-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Junior doctors in North Jutland Surgical Departments defined as PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.

Brief 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 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,

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Less than 4 months left at current job position.

Primary outcomes:
measure: MCSAT (Mayo Clinical Skills Assessment Tool)
timeFrame: 12 weeks
Secondary outcomes:
measure: Endoscopy training computer generated data - Percentage of colon visualized
timeFrame: 12 weeks
measure: Endoscopy training computer generated data - Time to cecum
timeFrame: 12 weeks
measure: Endoscopy training computer generated data - Estimated patient pain
timeFrame: 12 weeks
measure: Endoscopy training computer generated data: Percentage spent with clear view
timeFrame: 12 weeks
measure: Endoscopy training computer generated data - Total score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hobro
country: Denmark
facility: Aalborg University Hospital:Hobro
state: Jutland
city: Aalborg
country: Denmark
facility: NordSim, Aalborg University Hospital
city: Hjörring
country: Denmark
facility: Hjörring Hospial
Study officials:
affiliation: Aaborg University Surgical Department
name: Lasse Pedersen, m.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Preisler 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.
citation: Sedlack 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.
citation: Kaminski 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.