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
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer | Behavioral: Curriculum Group Behavioral: Self-directed learning group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | A Comprehensive Simulation-based Curriculum as a Means to Enhance Technical and Non-technical Skills in Colonoscopy: a Randomized Control Trial |
Actual Study Start Date : | June 2011 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |
Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Self-directed learning group |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto
Exclusion Criteria:
- Greater than 20 colonoscopies performed

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991522
Canada, Ontario | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B1W8 |
Principal Investigator: | Samir C Grover, MD | Unity Health Toronto |
Responsible Party: | Samir Grover, Principal Investigator, Unity Health Toronto |
ClinicalTrials.gov Identifier: | NCT01991522 |
Other Study ID Numbers: |
13-197c |
First Posted: | November 25, 2013 Key Record Dates |
Results First Posted: | November 5, 2018 |
Last Update Posted: | November 5, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |