Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments

Colorectal Cancer Clinical Trial

Official title:

Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02425657
• Other study ID #: AalborgH1
• Status: Recruiting
• Start date: September 14, 2016
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2019
• Source: Aalborg University Hospital
• Contact: Lasse Pedersen, m.d.
• Phone: (+45) 97661212
• Email: lasse.pedersen[@]rn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Harm Reduction
• Perforation During Colonoscopy

Intervention

Behavioral:
• Training of junior doctors
Training program

Locations

Country	Name	City	State
Denmark	NordSim, Aalborg University Hospital	Aalborg
Denmark	Hjörring Hospial	Hjörring
Denmark	Aalborg University Hospital:Hobro	Hobro	Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Nordsim

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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. — View 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. — View Citation

Preisler L, Svendsen MB, 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. — View 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. Erratum in: Gastrointest Endosc. 2011 Sep;74(3):729. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MCSAT (Mayo Clinical Skills Assessment Tool)	Measured at day 0,5,10,15 and 20.	12 weeks
Secondary	Endoscopy training computer generated data - Percentage of colon visualized	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks
Secondary	Endoscopy training computer generated data - Time to cecum	Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)	12 weeks
Secondary	Endoscopy training computer generated data - Estimated patient pain	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks
Secondary	Endoscopy training computer generated data: Percentage spent with clear view	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks
Secondary	Endoscopy training computer generated data - Total score	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks