Methods
Overview
Participants
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The initial goal should be to test 2-3 MIS or Bariatric surgeons at each institution who perform at least 25 cases a year which require laparoscopic suturing without using the robot or an assist device (e.g., Endo Stitch).
Multi-center study
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Consent Form
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Each participant will complete a consent form before testing at each institution (Download the file below).
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Testing
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Each participant will view an instructional video demonstrating roles for completion of each task prior to the testing.
Before testing, each participant will be allowed to perform the FLS suturing tasks (either intra or extracorporeal knot) up to 3 mins (at least 1 min) as a warm up. Each surgeon will perform the entire series of tasks twice in the following specified order using the standard FLS simulator. Testing will last about 90 mins but it depends on performance. During the testing, the camera and trocar locations need to be adjusted for each task. For saving time, two FLS simulators should be used for testing. Task 1. Needle Handling (cutoff time: 300 sec) Task 2. Offset Camera Forehand Suturing (600 sec) Task 3. Offset Camera Backhand Suturing (600 sec) Task 4. Confined Space Suturing (600 sec) Task 5. Suturing Under Tension (900 sec) Task 6. Continuous Suturing (1200 sec) All performance should be recorded (MPEG4, MOV, or WMV, etc) for further analyses (more information, go to Recording Performance). |
Post-test Survey
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Each participant will complete a paper-based questionnaire after testing (see the doc file below: click here).
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Assessment & Rater
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All performance should be videotaped for further data analyses: all files must be named using code.
General instructions to raters are described in the "attention to rater" (click here). 1 rater at each site should be timing. One participant at each site must be timed by two people to establish inter-rater reliability. Don’t use cell phone as a timer. We found that it is not an accurate measure and it is difficult to control. The time should be rounded up or down to the nearest second. e.g., 45.5 seconds = 46, 43.4 seconds = 43 If participants go over predefined cutoff time, they will be asked to stop and move on to the next task. For assessing error or penalty of the tasks: raters at McGill should be assessing errors except for the Needle Handling task. For Needle Handling task, the same rater at each site should score the penalty (needle outside the field of view). During testing, please label the penrose drains and supplies using a marker with a "1" or a "2" to indicate whether they were used during the first task repetition or the second. Also, please place the penrose drains and supplies with suture knots attached, in plastic baggies that are labeled with the participant name and task (e.g. "1st_CODE_TASK NAME" => "1st LH5 forehand", "2nd MG1 confined", etc.). Each task (penrose and supply) must be mailed in separate plastic baggies (total 10 baggies per participant) to McGill for scoring (address: DeKuyper Education Centre. Montreal General Hospital. D6-257, 1650 ave Cedar, Montreal, Quebec H3G 1A4 Canada; Tel +1-514-934-1934, ext.45390). |
Data collection
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Please code each participant before testing. E.g., McGill University, Participant #1 = MG1
Post-test survey and test scores of the tasks
Each site is required to have a Drop Box account in order to upload recorded performance with codes.
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Appendix for IRB
sample_of_irb.docx | |
File Size: | 2247 kb |
File Type: | docx |
Confidentiality
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The data collected in this study are classified as confidential. Confidential data are completely anonymous. All data obtained will be coded according to position of the participant. All data collected will be kept confidential and secured in a locked area in the office of the principal investigator at each site. Once the results are submitted for publication, the data will only be made available to editors involved in the review and publication process, as well, the data will be available for open sharing between qualified investigators who are involved in a similar area of study. Only the non-identifiable data will be retained for at least five years after publication.
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Anticipated Ethical Issues
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This study will not involve or affect patients. Consent forms will take into consideration the well-being, free-will and respect of the participants, including respect of privacy. Participants can choose to withdraw at any point during the study and they will be made explicitly aware of this at the time of informed consent. Participants will be assured that their performance would not change their practice. All data will be for research purposes only and will not be used in any way for the formal evaluation of the competence or skill level of the physician.
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