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Trial record 84 of 318 for:    colon cancer | ( Map: Canada )

A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy

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ClinicalTrials.gov Identifier: NCT01991522
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Samir Grover, St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE April 28, 2017
Results First Posted Date  ICMJE November 5, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
Transfer of Skills to Clinical Colonoscopy [ Time Frame: less than 2 weeks ]
The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. These were measured across two endoscopic procedures, performed consecutively within two weeks of completion of the course. Data from two procedures were used to limit the influence of spurious findings from single procedures.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Transfer of Skills to Clinical Colonoscopy [ Time Frame: less than 2 weeks ]
The primary outcome measure is the transfer of learned skills to real-patient colonoscopies after completion of the training intervention, as assessed by blinded expert endoscopists using the Direct Observation of Procedural Skills (DOPS), a validated task-specific performance measure.
Change History Complete list of historical versions of study NCT01991522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
Retention of Clinical Skills [ Time Frame: 4-6 weeks after intervention ]
The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Retention of Clinical Skills [ Time Frame: 4-6 weeks after intervention ]
The secondary outcome is performance during an integrated scenario, a test of transfer wherein the participant performs a colonoscopy while interacting with a standardized patient. This will occur 4-6 weeks after the interventions and will be assessed by expert endoscopists using validated task-specific scoring schemata for technical skills, communication skills and global scales.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy
Official Title  ICMJE A Comprehensive Simulation-based Curriculum as a Means to Enhance Technical and Non-technical Skills in Colonoscopy: a Randomized Control Trial
Brief Summary Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. The optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Behavioral: Curriculum Group
  • Behavioral: Self-directed learning group
Study Arms  ICMJE
  • Experimental: Curriculum Group
    The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
    Intervention: Behavioral: Curriculum Group
  • Active Comparator: Self-directed learning group
    The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
    Intervention: Behavioral: Self-directed learning group
Publications * Grover SC, Garg A, Scaffidi MA, Yu JJ, Plener IS, Yong E, Cino M, Grantcharov TP, Walsh CM. Impact of a simulation training curriculum on technical and nontechnical skills in colonoscopy: a randomized trial. Gastrointest Endosc. 2015 Dec;82(6):1072-9. doi: 10.1016/j.gie.2015.04.008. Epub 2015 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2018)
33
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
30
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto

Exclusion Criteria:

  • Greater than 20 colonoscopies performed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01991522
Other Study ID Numbers  ICMJE 13-197c
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samir Grover, St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samir C Grover, MD St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP