- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05086783
Video-based Coaching (VBC) in Gynecologic Surgery
A Multicentre, Randomized Controlled Trial to Assess Video-based Feedback for Surgical Coaching in Gynecology and Gynecologic Oncology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Achieving technical excellence is a core component of surgical training. Historically, a combination of didactic teaching, surgical simulation and the master-apprentice model (MAM) were the cornerstone of surgical education. With restrictions on resident duty hours and operating time with the COVID-19 pandemic and a shift to competency-based medical education, there is an opportunity to transform surgical education and improve educational efficiency. The purpose of this study is to assess the effect of video-based coaching (VBC) on resident skill acquisition in laparoscopic suturing of the vaginal vault at the time of laparoscopic hysterectomy.
Participants will include year 3 to 5 Obstetrics and Gynecology residents completing gynecology and gynecologic oncology rotations at the study sites. Participants will be randomized to the control (standard surgical curriculum) and intervention (standard curriculum and VBC) arms on the day of the first attempt. The effectiveness of VBC will be measured by the difference in baseline and post-intervention standardized blinded score between the intervention and control group during laparoscopic closure of the vaginal cuff.
All residents will be video recorded performing laparoscopic closure of the vaginal cuff at the time of hysterectomy using video recording built into the laparoscopic equipment in the operating rooms. Residents in the control group will receive standard surgical teaching (MAM), then they will be video-recorded performing the skill at their second attempt. Residents in the intervention group will receive the standard surgical teaching plus the intervention of reviewing the recorded video with the surgical coach at the end of the procedure (MAM plus VBC). The surgical coach will provide specific personalized feedback on performance and suggestions for improvement following the Wisconsin Coaching Framework during their coaching session. Participants will then be recorded on their subsequent attempt.
All raw video footage will be edited to include only the relevant portion of the film. This will facilitate the assessment process (i.e., the assessors will view only the relevant footage). The edited video segments for both groups on both attempts will be scored independently using the validated surgical assessment tool by two blinded, experienced gynecologic laparoscopists to evaluate surgical performance (blinded to attempt number and randomization group). The average score between both assessors will be used for statistical analysis. The effectiveness of VBC will be evaluated by comparing the difference in assessment scores between the baseline and post-intervention scores between the control and intervention groups.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brenna Swift
- Phone Number: 647-520-8468
- Email: brenna.swift@mail.utoronto.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- SunnyBrook Health Sciences Centre
-
Contact:
- Danielle Vicus, MD
- Phone Number: (416) 480-4378
- Email: danielle.vicus@sunnybrook.ca
-
Toronto, Ontario, Canada, M5G 1Z5
- Not yet recruiting
- University Health Network
-
Contact:
- Stephane Laframboise, MD
- Phone Number: (416) 946-2254
- Email: stephane.laframboise@uhn.ca
-
Toronto, Ontario, Canada, M5G 1Z5
- Recruiting
- Mount Sinai Hospital
-
Contact:
- Evan Tannenbaum, MD, MSc
- Phone Number: 3758 416-586-4800
- Email: Evan.Tannenbaum@sinaihealth.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postgraduate year (PGY) 3 to 5 residents in the Obstetrics and Gynaecology program at the University of Toronto
- Completing chief gynecology rotation at Mount Sinai Hospital (MSH) and Sunnybrook Health Sciences Centre (SHSC), and gynecologic oncology rotation at University Health Network (UHN) and SHSC form Sept 2021 until June 2022
Exclusion Criteria:
- Previous participation in study on another rotation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video-based coaching
Participants in the intervention arm will receive the standard surgical teaching while in the operating room (master-apprentice model (MAM)), plus the intervention of reviewing the recorded video with the surgical coach after performing their first attempt at laparoscopic closure of the vaginal vault.
|
The coaching session will follow the Wisconsin Coaching Framework (Greenberg 2015).
The surgical coaching session will last at maximum 30 minutes and will occur within 1-2 week following the procedure.
The surgical coaching session will occur over Zoom.
The second attempt will occur within 1 week following the coaching session.
Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).
|
Placebo Comparator: Standard surgical teaching
Participants in the control arm will receive the standard surgical teaching while in the operating room (master-apprentice model-(MAM)).
|
Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from baseline in modified-OSATS (Objective Structured Assessment of Technical Skill) score after video-based coaching intervention compared to control of standard surgical teaching
Time Frame: The first and second attempt will occur within a 1 month timeframe. The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
|
The modified OSATS score is a standardized rubric for assessing technical skills
|
The first and second attempt will occur within a 1 month timeframe. The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant assessment of desirability of video-based surgical coaching
Time Frame: Desirability will be calculated at the end of study enrolment within 1 year,
|
Desirability of the intervention will be evaluated based on the proportion of eligible residents who enrol in the study (number enrolled/number eligible).
|
Desirability will be calculated at the end of study enrolment within 1 year,
|
Participant assessment of usefulness of video-based surgical coaching
Time Frame: Questionnaire to be completed by participant within 1 month of second attempt.
|
Participants in the intervention arm will complete a surgical coachee questionnaire to determine if the participants in the intervention arm found the coaching experience to be useful for developing their surgical skills.
|
Questionnaire to be completed by participant within 1 month of second attempt.
|
Surgical coach assessment of feasibility of video-based surgical coaching
Time Frame: Questionnaire to be completed by surgical coach on day of coaching session and all questionnaires will be completed within 1 year.
|
Surgical coach will complete a questionnaire immediately after the coaching activity, which will collect time for video-editing, time for coaching session and receptivity of the participant to coaching
|
Questionnaire to be completed by surgical coach on day of coaching session and all questionnaires will be completed within 1 year.
|
Inter-rater reliability of the video evaluations by the blinded, experienced laparoscopists
Time Frame: The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
|
The intraclass correlation coefficient (ICC) between the two score for each video will be calculated
|
The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evan Tannenbaum, MD, MSc, Mount Sinai Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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