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

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) .

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Harm Reduction; Perforation During Colonoscopy
• Intervention / Treatment: Behavioral: Training of junior doctors

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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Lasse Pedersen, m.d.; Phone Number: (+45) 97661212; Email: lasse.pedersen@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • NordSim, Aalborg University Hospital
    • Contact: Lasse L Pedersen, m.d.; Phone Number: +4597661212; Email: lasse.pedersen@rn.dk
    • Principal Investigator: Inge Bernstein, PhD, MHM
  • Hjörring, Denmark, 9800
    • Recruiting
    • Hjörring Hospial
    • Contact: Lasse Pedersen, m.d.; Phone Number: +45 97661212; Email: lasse.pedersen@rn.dk
  • Jutland
    • Hobro, Jutland, Denmark, 9500
      • Recruiting
      • Aalborg University Hospital:Hobro
      • Contact: Lasse Pedersen, m.d.; Phone Number: +45 97661212; Email: lasse.pedersen@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Junior Doctors; Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2).	Behavioral: Training of junior doctors; Training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MCSAT (Mayo Clinical Skills Assessment Tool)	Measured at day 0,5,10,15 and 20.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopy training computer generated data - Percentage of colon visualized	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks
Endoscopy training computer generated data - Time to cecum	Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)	12 weeks
Endoscopy training computer generated data - Estimated patient pain	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks
Endoscopy training computer generated data: Percentage spent with clear view	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks
Endoscopy training computer generated data - Total score	Computer generated score (Simulator test performed at day 0, 10 and 20)	12 weeks

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Nordsim
• Investigators: Principal Investigator: Lasse Pedersen, m.d., Aaborg University Surgical Department

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Training; Colonoscopy; Education; Fast track
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: AalborgH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO