Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05103449 |
| Other study ID # |
STU-2021-0805 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 3, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Randomized controlled trial to evaluate the effect of video-based coaching on Obstetrics and
Gynecology residents' efficiency, proficiency, and confidence in performing laparoscopic
salpingectomy.
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.
