- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05103449
Effect of Video-Based Coaching on Resident Laparoscopic Surgical Skills
August 22, 2023 updated by: Lisa Chao, University of Texas Southwestern Medical Center
Effect of Video-Based Coaching on Resident Laparoscopic Surgical Skills: A Randomized Controlled Trial
Randomized controlled trial to evaluate the effect of video-based coaching on Obstetrics and Gynecology residents' efficiency, proficiency, and confidence in performing laparoscopic salpingectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
University of Texas Southwestern PGY-1 and PGY-2 Obstetrics and Gynecology residents will be scheduled to complete a 4-week gynecology rotation at Parkland Memorial Hospital.
After completing the pre-survey, trainees will be randomized into either the control or experimental group (video coached group) stratified by PGY (Post-Graduate Year) level.
Minimum group sample sizes of 9 and 9 to achieve 90% power to detect a difference of 5.0 in a design with 3 repeated measurements having a Simple covariance structure when the standard deviation is 5.4 and the alpha level is 0.05.
The control group will be video recorded performing three laparoscopic salpingectomy procedures as scheduled during the 4-week block.
The control group will not participate in video coaching sessions.
The experimental group will be video recorded performing three laparoscopic salpingectomy procedures as scheduled during the block.
After the first and second laparoscopic salpingectomy, the experimental group of residents will review their video recording and receive a video coaching session by a minimally invasive gynecologic surgery (MIGS) attending physician prior to the next surgery.
All three video recordings for each participant (control and experimental group) will be graded using Global Operative Assessment of Laparoscopic Skills (GOALS) and Objective Structured Assessment of Laparoscopic Salpingectomy (OSA-LS) criteria by two attending physicians not involved in the surgeries or coaching.
Each surgery will be blinded to the group allocation and the week definition.
Participants will not be given the assessment score and the score will not affect evaluations.
After the third laparoscopic salpingectomy, trainees will fill out a post-course survey to determine if the video-based coaching course improved their proficiency and confidence in laparoscopic gynecologic surgery.
They will also watch their own laparoscopic salpingectomy video recording and self-grade their skills using the GOALS and OSA-LS criteria that will be provided in the post-survey.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- PGY-1 and PGY-2 UTSW OB/GYN Residents during their Gynecology Block
Exclusion Criteria:
- Residents who have previously participated in the study
- PGY-3 or PGY-4 residents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group (No Video Coaching)
|
|
|
Experimental: Experimental Group (Video Coaching)
Video-based coaching group
|
Video-based coaching sessions after salpingectomy 1 and 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GOALS scores on participants' last salpingectomy video
Time Frame: From Week 1 to Week 4
|
Global Operative Assessment of Laparoscopic Skills (GOALS) is a validated assessment scale for laparoscopic surgery.
GOALS has maximum of 5 points in each of 5 categories, highest score = 25.
|
From Week 1 to Week 4
|
|
OSA-LS scores on participants' last salpingectomy video
Time Frame: From Week 1 to Week 4
|
Objective Structured Assessment of Laparoscopic Salpingectomy (OSA-LS) is a validated assessment scale for laparoscopic salpingectomy.
OSA-LS has maximum of 5 points in each of 10 categories, highest score = 50.
|
From Week 1 to Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to complete salpingectomy
Time Frame: From Week 1 to Week 4
|
Time to complete salpingectomy from start of procedure (instruments inserted to begin salpingectomy) to end of procedure (removal of fallopian tube from trocar)
|
From Week 1 to Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa Chao, MD, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 20, 2021
First Posted (Actual)
November 2, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STU-2021-0805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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