Surgical VideosNCT03230552
Effect of Pre-operative Training Using Surgical Videos on Resident Performance of Unilateral Salpigo-oophrectomy
A study testing Instructional surgical video in people with Surgical Videos and Pre-operative Training, run by Unity Health Toronto at 1 site in Canada.
Trial summary
There is a need for the development and validation of new teaching strategies and resources for surgical training that can occur outside of the operating room. The use of surgical videos is not novel however it has not been validated as an effective approach for gynecologic surgical training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Videos, Pre-operative Training
- What is being tested?
- Instructional surgical video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 1 Aug 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Novice OBGYN residents who have performed <10 LSO surgeries as the primary surgeon
Who cannot join
- OBGYN residents who have performed > 10 LSO surgeries as the primary surgeon.
Trial locations and contacts
1 site in 1 country.
About this study
There is a need for the development and validation of new teaching strategies and resources for surgical training that can occur outside of the operating room. The use of surgical videos is not novel however it has not been validated as an effective approach for gynecologic surgical training. The goals of our study are to (1) develop an educational surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the effectiveness of this tool in preparing residents for performance in the operating room.
Read the detailed description
In the rapidly changing face of surgical education and with a pressure to adopt competency-based training and assessment nationwide, obstetrics and gynecology residency programs will be forced to implement effective strategies to ensure that learners acquire the skill set required to become competent gynecologists. However, very few instructional tools have been validated in gynecologic surgery. The use of surgical videos as a teaching strategy may be one piece to this puzzle. Surgical videos are becoming increasingly popular, however, their value as an effective instructional technique has yet to be validated. Should surgical videos prove to be of benefit in surgical training it would offer an alternate modality to optimize operating room experiences and learning for gynecology residents.
Obstetrics and gynecology residents in years one and two of their training (junior residents), will view a teaching video about LSO (intervention group) compared to not watching a video (control group) to assess if our intervention results in better performance in the operating room for this procedure as rated by an objective structured assessment of technical skills tool (OSAT) (primary outcome). Secondary outcome measures will include a self-administered questionnaire grading knowledge and confidence, and a 5-point Likert scale grading resident satisfaction with the video.
- Conditions
- Surgical Videos, Pre-operative Training
- Being tested
- Instructional surgical video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructional surgical videoOther
An instructional surgical video shown to residents before they perform LSO surgery.
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | Residents assigned to this group will watch an instructional surgical video prior to LSO surgery. Receives: Other: Instructional surgical video |
| No video group | No intervention | Residents assigned to this group will not watch an instructional surgical video prior to LSO surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Structure Assessment of Technical Skills Tool (OSAT)
Surgeries performed by the residents will be video recorded. Resident performance during surgery will be rated using the OSAT tool.
Measured: Intraoperative (Beginning of surgery to end of surgery)
Secondary outcomes (1)
Pre-operative knowledge survey
Residents will complete a survey prior surgery which will measure their pre-operative knowledge of performing LSO procedure.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
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 Surgical VideosStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliane Shore, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230552
- Sponsor's protocol ID
- 17-124
- Status last verified
- Feb 2019
- First submitted
- 24 Jul 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norris S, Papillon-Smith J, Gagnon LH, Jacobson M, Sobel M, Shore EM. Effect of a Surgical Teaching Video on Resident Performance of a Laparoscopic Salpingo-oophorectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2020 Nov-Dec;27(7):1545-1551. doi: 10.1016/j.jmig.2020.01.010. Epub 2020 Jan 23.
PubMed 31982585
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Training Using Surgical Videos on Resident Performance of Unilateral Salpigo-oophrectomy
- ClinicalTrials.gov ID
- NCT03230552
- Acronym / sponsor ID
- 17-124
- Conditions
- Surgical Videos, Pre-operative Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 26 Jul 2017 (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.
There is a need for the development and validation of new teaching strategies and resources for surgical training that can occur outside of the operating room. The use of surgical videos is not novel however it has not been validated as an effective approach for gynecologic surgical training. The goals of our study are to (1) develop an educational surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the effectiveness of this tool in preparing residents for performance in the operating room.
Detailed description
In the rapidly changing face of surgical education and with a pressure to adopt competency-based training and assessment nationwide, obstetrics and gynecology residency programs will be forced to implement effective strategies to ensure that learners acquire the skill set required to become competent gynecologists. However, very few instructional tools have been validated in gynecologic surgery. The use of surgical videos as a teaching strategy may be one piece to this puzzle. Surgical videos are becoming increasingly popular, however, their value as an effective instructional technique has yet to be validated. Should surgical videos prove to be of benefit in surgical training it would offer an alternate modality to optimize operating room experiences and learning for gynecology residents.
Obstetrics and gynecology residents in years one and two of their training (junior residents), will view a teaching video about LSO (intervention group) compared to not watching a video (control group) to assess if our intervention results in better performance in the operating room for this procedure as rated by an objective structured assessment of technical skills tool (OSAT) (primary outcome). Secondary outcome measures will include a self-administered questionnaire grading knowledge and confidence, and a 5-point Likert scale grading resident satisfaction with the video.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Video group | Experimental | Other: Instructional surgical videoResidents assigned to this group will watch an instructional surgical video prior to LSO surgery. |
| No video group | No intervention | –Residents assigned to this group will not watch an instructional surgical video prior to LSO surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Novice OBGYN residents who have performed <10 LSO surgeries as the primary surgeon
Key exclusion criteria (1 listed)
- OBGYN residents who have performed > 10 LSO surgeries as the primary surgeon.
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 |
|---|---|---|
| Instructional surgical videoAn instructional surgical video shown to residents before they perform LSO surgery. | Other | Video group |
Primary outcome
Objective Structure Assessment of Technical Skills Tool (OSAT)
Time frame: Intraoperative (Beginning of surgery to end of surgery)
Surgeries performed by the residents will be video recorded. Resident performance during surgery will be rated using the OSAT tool.
1 secondary outcome
Pre-operative knowledge survey
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 31982585Norris S, Papillon-Smith J, Gagnon LH, Jacobson M, Sobel M, Shore EM. Effect of a Surgical Teaching Video on Resident Performance of a Laparoscopic Salpingo-oophorectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2020 Nov-Dec;27(7):1545-1551. doi: 10.1016/j.jmig.2020.01.010. Epub 2020 Jan 23.
- 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.
Eliane Shore, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructional surgical video in people with Surgical Videos and Pre-operative Training, run by Unity Health Toronto at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2019. 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 Canada. 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?
Results are not available in the source record.
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?
Objective Structure Assessment of Technical Skills Tool (OSAT) (time frame: Intraoperative (Beginning of surgery to end of surgery)). 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 NCT03230552, 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 20 Feb 2019.