Laparoscopic SalpingectomyNCT05103449
Effect of Video-Based Coaching on Resident Laparoscopic Surgical Skills
A study testing Video Coaching in people with Laparoscopic Salpingectomy, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Salpingectomy
- What is being tested?
- Video Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PGY-1 and PGY-2 UTSW OB/GYN Residents during their Gynecology Block
Who cannot join
- Residents who have previously participated in the study
- PGY-3 or PGY-4 residents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Laparoscopic Salpingectomy
- Being tested
- Video Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video CoachingOther
Video-based coaching sessions after salpingectomy 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Control Group (No Video Coaching) | No intervention | Control Group (No Video Coaching) |
| Experimental Group (Video Coaching) | Experimental | Video-based coaching group Receives: Other: Video Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOALS scores on participants' last salpingectomy video
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.
Measured: From Week 1 to Week 4
OSA-LS scores on participants' last salpingectomy video
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.
Measured: From Week 1 to Week 4
Secondary outcomes (1)
Time to complete salpingectomy
Time to complete salpingectomy from start of procedure (instruments inserted to begin salpingectomy) to end of procedure (removal of fallopian tube from trocar)
Measured: From Week 1 to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start3 Oct 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SalpingectomyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Chao, University of Texas Southwestern Medical Center
- Investigators
- Lisa Chao, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103449
- Sponsor's protocol ID
- STU-2021-0805
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muir TM, Pruszynski J, Kho KA, Ramirez CI, Donnellan NM, Chao L. Video-Based Coaching for Laparoscopic Salpingectomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Sep 1;144(3):358-365. doi: 10.1097/AOG.0000000000005677. Epub 2024 Jul 25.
PubMed 39053009
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video-Based Coaching on Resident Laparoscopic Surgical Skills: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05103449
- Acronym / sponsor ID
- STU-2021-0805
- Conditions
- Laparoscopic Salpingectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial to evaluate the effect of video-based coaching on Obstetrics and Gynecology residents' efficiency, proficiency, and confidence in performing laparoscopic salpingectomy.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (No Video Coaching) | No intervention | –Control Group (No Video Coaching) |
| Experimental Group (Video Coaching) | Experimental | Other: Video CoachingVideo-based coaching group |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PGY-1 and PGY-2 UTSW OB/GYN Residents during their Gynecology Block
Key exclusion criteria (2 listed)
- Residents who have previously participated in the study
- PGY-3 or PGY-4 residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video CoachingVideo-based coaching sessions after salpingectomy 1 and 2 | Other | Experimental Group (Video Coaching) |
Primary outcome
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.
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.
1 secondary outcome
Time to complete salpingectomy
Time frame: From Week 1 to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 39053009Muir TM, Pruszynski J, Kho KA, Ramirez CI, Donnellan NM, Chao L. Video-Based Coaching for Laparoscopic Salpingectomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Sep 1;144(3):358-365. doi: 10.1097/AOG.0000000000005677. Epub 2024 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Chao, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Coaching in people with Laparoscopic Salpingectomy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOALS scores on participants' last salpingectomy video (time frame: From Week 1 to Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.