NCT02425657

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) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

April 10, 2015

Last Update Submit

July 2, 2019

Conditions

Harm ReductionPerforation During ColonoscopyColorectal Cancer

Keywords

EducationTrainingFast trackColonoscopy

Outcome Measures

Primary Outcomes (1)

  • MCSAT (Mayo Clinical Skills Assessment Tool)

    Measured at day 0,5,10,15 and 20.

    12 weeks

Secondary Outcomes (5)

  • Endoscopy training computer generated data - Percentage of colon visualized

    12 weeks

  • Endoscopy training computer generated data - Time to cecum

    12 weeks

  • Endoscopy training computer generated data - Estimated patient pain

    12 weeks

  • Endoscopy training computer generated data: Percentage spent with clear view

    12 weeks

  • Endoscopy training computer generated data - Total score

    12 weeks

Study Arms (1)

Junior Doctors

Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2).

Behavioral: Training of junior doctors

Interventions

Training of junior doctorsBEHAVIORAL

Training program

Junior Doctors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Junior doctors in North Jutland Surgical Departments defined as PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.

You may qualify if:

  • 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.

You may not qualify if:

  • Less than 4 months left at current job position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aalborg University Hospital:Hobro

Hobro, Jutland, 9500, Denmark

RECRUITING

NordSim, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Hjörring Hospial

Hjørring, 9800, Denmark

RECRUITING

Related 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. No abstract available.

    PMID: 25034851BACKGROUND

  • 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.

    PMID: 25634177BACKGROUND

  • 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.

    PMID: 21514931BACKGROUND

  • 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.

    PMID: 25670810BACKGROUND

MeSH Terms

Conditions

Harm ReductionColorectal Neoplasms

Condition Hierarchy (Ancestors)

BehaviorIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Lasse Pedersen, m.d.

    Aaborg University Surgical Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lasse Pedersen, m.d.

CONTACT

(+45) 97661212lasse.pedersen@rn.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.-student

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 24, 2015

Study Start

September 14, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)