NCT05086783

Brief Summary

This multi-centre, randomized controlled trial aims to assess the role of video-based coaching (VBC) in residency education in gynecologic and gynecologic oncology surgery. It involves a trainee and a surgical coach, who together review a recording of the trainee performing a surgical skill or procedure and coaching is provided for skill improvement. Resident performance will be evaluated using a standardized scoring scale by two experienced surgeons before and after the intervention and compared to the control group receiving the standard surgical teaching curriculum.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

September 28, 2021

Last Update Submit

October 7, 2021

Conditions

Keywords

Surgical educationCoachLaparoscopyGynecologic surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (4)

  • Participant assessment of desirability of video-based surgical coaching

    Desirability will be calculated at the end of study enrolment within 1 year,

  • Participant assessment of usefulness of video-based surgical coaching

    Questionnaire to be completed by participant within 1 month of second attempt.

  • Surgical coach assessment of feasibility of video-based surgical 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

    The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.

Study Arms (2)

Video-based coaching

EXPERIMENTAL

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.

Other: Video-based coachingOther: Standard surgical teaching (master-apprentice model - (MAM))

Standard surgical teaching

PLACEBO COMPARATOR

Participants in the control arm will receive the standard surgical teaching while in the operating room (master-apprentice model-(MAM)).

Other: Standard surgical teaching (master-apprentice model - (MAM))

Interventions

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.

Video-based coaching

Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).

Standard surgical teachingVideo-based coaching

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous participation in study on another rotation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 1Z5, Canada

NOT YET RECRUITING

MeSH Terms

Interventions

Sarcoglycans

Intervention Hierarchy (Ancestors)

Dystrophin-Associated ProteinsMuscle ProteinsContractile ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsMembrane Glycoproteins

Study Officials

  • Evan Tannenbaum, MD, MSc

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, the participants and the surgical coach will not be blinded. The participants will be informed of their assignment after completing the first attempt. The staff surgeon in the operating room for each attempt will be blinded. The experienced laparoscopists who will be scoring the videos will be blinded to the group allocation and the attempt number.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomized to the intervention (video-based coaching plus standard surgical teaching following the master-apprentice model) or the control (standard surgical teaching following the master-apprentice model)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Obstetrician/Gynecologist

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 21, 2021

Study Start

October 6, 2021

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations