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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Colorectal Cancer
Interventions Behavioral: Curriculum Group
Behavioral: Self-directed learning group
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Curriculum Group Self-directed Learning Group
Hide Arm/Group Description 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. The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Period Title: Overall Study
Started 16 17
Completed 16 17
Not Completed 0 0
Arm/Group Title Curriculum Group Self-directed Learning Group Total
Hide Arm/Group Description 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. The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training. Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
17
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
28.4  (1.3) 29.7  (3.8) 29.1  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
9
  56.3%
4
  23.5%
13
  39.4%
Male
7
  43.8%
13
  76.5%
20
  60.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Training program (gastroenterology, general surgery, or internal medicine)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Gastroenterology
8
  50.0%
4
  23.5%
12
  36.4%
General surgery
8
  50.0%
11
  64.7%
19
  57.6%
Internal Medicine
0
   0.0%
2
  11.8%
2
   6.1%
Number of independent colonoscopies performed  
Mean (Standard Deviation)
Unit of measure:  Colonoscopies
Number Analyzed 16 participants 17 participants 33 participants
0.6  (2.5) 0.7  (2.9) 0.65  (2.7)
Number of assisted colonoscopies performed  
Mean (Standard Deviation)
Unit of measure:  Colonoscopies
Number Analyzed 16 participants 17 participants 33 participants
2.7  (7.7) 0.8  (1.5) 1.7  (4.5)
1.Primary Outcome
Title Transfer of Skills to Clinical Colonoscopy
Hide Description 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.
Time Frame less than 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curriculum Group Self-directed Learning Group
Hide Arm/Group Description:
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.
The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Procedure 1 72.2  (10.9) 31.8  (14.8)
Procedure 2 71.9  (16.7) 32.3  (18.3)
2.Secondary Outcome
Title Retention of Clinical Skills
Hide Description 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.
Time Frame 4-6 weeks after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curriculum Group Self-directed Learning Group
Hide Arm/Group Description:
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.
The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Colonoscopy-specific performance 67  (12.1) 54.3  (14.3)
Communication skills 83.1  (5.7) 75.9  (9.7)
Global performance 69.4  (7) 63.5  (8.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curriculum Group Self-directed Learning Group
Hide Arm/Group Description 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. The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
All-Cause Mortality
Curriculum Group Self-directed Learning Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Curriculum Group Self-directed Learning Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Curriculum Group Self-directed Learning Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Samir C. Grover
Organization: St. Michael's
Phone: 416-864-5628
EMail: samir.grover@utoronto.ca
Layout table for additonal information
Responsible Party: Samir Grover, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01991522     History of Changes
Other Study ID Numbers: 13-197c
First Submitted: November 18, 2013
First Posted: November 25, 2013
Results First Submitted: April 28, 2017
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018