Educational ProblemsNCT04524988
Comparing Proficiency of Laparoscopic Vaginal Cuff Suturing After Laparoscopic Training in Surgically Naive Students
A study testing Laparoscopic Simulation Training in people with Educational Problems, run by Northwestern University at 1 site in United States.
Trial summary
Surgically naive premedical and medical students were trained on two different laparoscopic simulation trainers, then tested on the same vaginal cuff suturing model. Video recordings were collected from the vaginal cuff suturing tasks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Problems
- What is being tested?
- Laparoscopic Simulation Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current student enrolled in premedical internship program at Northwestern during recruitment dates
- current medical student in M1/M2 preclinical years enrolled in accredited medical school
- MD/PhD student in their PhD year(s) enrolled in accredited medical school
Who cannot join
- medical student in M3/M4 clinical years enrolled in accredited medical school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Surgical Proficiency of Laparoscopic Vaginal Cuff Suturing in Surgically Naïve Learners After Training With Two Different Laparoscopic Simulators: A Randomized Controlled Trial
Surgically naive premedical and medical students were trained on two different laparoscopic simulation trainers, then tested on the same vaginal cuff suturing model. Video recordings were collected from the vaginal cuff suturing tasks. These recordings were graded by expert gynecologic surgeons using a laparoscopic skills rubric. Their scores were compared to determine if one of the two laparoscopic trainers better prepared surgically naive students to complete a gynecologic surgical task.
Read the detailed description
Surgically naive premedical and medical students were recruited from June-November 2019. They were block randomized into two laparoscopic simulation training groups: Essentials in Minimally Invasive Gynecology (EMIG) or Fundamentals of Laparoscopic Surgery (FLS). Demographic data was collected from all participants. Participants watched instructional videos specific to their simulation trainer, as well as a video for the vaginal cuff suturing task. Participants then completed a pre-test on a vaginal cuff laparoscopic suturing model. They underwent EMIG or FLS training for approximately 2.5 hours. After training, they completed a post-test on the same vaginal cuff laparoscopic suturing model. Both pre- and post-test tasks were recorded. Video recordings were reviewed and graded by two expert high-volume MIGS surgeons who were masked to participant group (EMIG or FLS) and test phase (pre- or post-test). A modified version of the previously validated GOALS tool was used for grading. Participants also completed a survey rating their confidence level in performing laparoscopic tasks using a 5-point Likert scale after completion of their post-test vaginal cuff suturing task.
- Conditions
- Educational Problems
- Being tested
- Laparoscopic Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Simulation TrainingProcedure or surgery
All participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).
| Study group | Role | What they receive |
|---|---|---|
| Fundamentals of Laparoscopic Surgery (FLS) | Active comparator | This group will undergo 2.5h of training on the current standard laparoscopic simulation trainer (FLS), including the following tasks: peg transfer, intracorporeal knot tying and ligating loop. Receives: Procedure: Laparoscopic Simulation Training |
| Essentials in Minimally Invasive Gynecology (EMIG) | Experimental | This group will undergo 2.5h of training on a new gynecology-specific laparoscopic simulation trainer (EMIG), including the following tasks: peg transfer, intracorporeal knot tying and running suture. Receives: Procedure: Laparoscopic Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators
Using a previously validated laparoscopic skills assessment tool (Global Operative Assessment of Laparoscopic Skills, or GOALS), two expert MIGS surgeons reviewed each video and scored it using a modified version of the GOALS tool. Each participant was ultimately given a GOALS composite score, which was made up of 8 individual skill domains (3 of which were added to make the scoring relevant and specific to the vaginal cuff suturing task). The GOALS scores serve to measure student surgical proficiency at laparoscopic tasks.
Measured: 4 hours
Secondary outcomes (1)
Correlation of fine motor skills task experience with laparoscopic surgical task performance
Demographic data was collected from each participant in a survey prior to their training session. This data included experience with fine motor skills tasks, including video games, sewing and playing an instrument. As above, objective performance scores were obtained after video grading using a modified version of the GOALS tool. GOALS scores from participants with fine motor skills task performance were compared with GOALS scores for participants without the same prior fine motor skills task experience to assess for associations between performance and previous fine motor skill task experience.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start5 Jun 2019
- Primary completion15 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Milad, MD, Northwestern University
- Investigators
- Magdy Milad, MD, Principal investigator, Northwestern UniversityEmily Lin, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524988
- Sponsor's protocol ID
- STU00209340
- Status last verified
- Aug 2020
- First submitted
- 17 May 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Surgical Proficiency of Laparoscopic Vaginal Cuff Suturing in Surgically Naïve Learners After Training With Two Different Laparoscopic Simulators: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04524988
- Acronym / sponsor ID
- STU00209340
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Aug 2020 (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.
Surgically naive premedical and medical students were trained on two different laparoscopic simulation trainers, then tested on the same vaginal cuff suturing model. Video recordings were collected from the vaginal cuff suturing tasks. These recordings were graded by expert gynecologic surgeons using a laparoscopic skills rubric. Their scores were compared to determine if one of the two laparoscopic trainers better prepared surgically naive students to complete a gynecologic surgical task.
Detailed description
Surgically naive premedical and medical students were recruited from June-November 2019. They were block randomized into two laparoscopic simulation training groups: Essentials in Minimally Invasive Gynecology (EMIG) or Fundamentals of Laparoscopic Surgery (FLS). Demographic data was collected from all participants. Participants watched instructional videos specific to their simulation trainer, as well as a video for the vaginal cuff suturing task. Participants then completed a pre-test on a vaginal cuff laparoscopic suturing model. They underwent EMIG or FLS training for approximately 2.5 hours. After training, they completed a post-test on the same vaginal cuff laparoscopic suturing model. Both pre- and post-test tasks were recorded. Video recordings were reviewed and graded by two expert high-volume MIGS surgeons who were masked to participant group (EMIG or FLS) and test phase (pre- or post-test). A modified version of the previously validated GOALS tool was used for grading. Participants also completed a survey rating their confidence level in performing laparoscopic tasks using a 5-point Likert scale after completion of their post-test vaginal cuff suturing task.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fundamentals of Laparoscopic Surgery (FLS) | Active comparator | Procedure: Laparoscopic Simulation TrainingThis group will undergo 2.5h of training on the current standard laparoscopic simulation trainer (FLS), including the following tasks: peg transfer, intracorporeal knot tying and ligating loop. |
| Essentials in Minimally Invasive Gynecology (EMIG) | Experimental | Procedure: Laparoscopic Simulation TrainingThis group will undergo 2.5h of training on a new gynecology-specific laparoscopic simulation trainer (EMIG), including the following tasks: peg transfer, intracorporeal knot tying and running suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current student enrolled in premedical internship program at Northwestern during recruitment dates
- current medical student in M1/M2 preclinical years enrolled in accredited medical school
- MD/PhD student in their PhD year(s) enrolled in accredited medical school
Key exclusion criteria (1 listed)
- medical student in M3/M4 clinical years enrolled in accredited medical school
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 |
|---|---|---|
| Laparoscopic Simulation TrainingAll participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG). | Procedure or surgery | Essentials in Minimally Invasive Gynecology (EMIG), Fundamentals of Laparoscopic Surgery (FLS) |
Primary outcome
Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators
Time frame: 4 hours
Using a previously validated laparoscopic skills assessment tool (Global Operative Assessment of Laparoscopic Skills, or GOALS), two expert MIGS surgeons reviewed each video and scored it using a modified version of the GOALS tool. Each participant was ultimately given a GOALS composite score, which was made up of 8 individual skill domains (3 of which were added to make the scoring relevant and specific to the vaginal cuff suturing task). The GOALS scores serve to measure student surgical proficiency at laparoscopic tasks.
1 secondary outcome
Correlation of fine motor skills task experience with laparoscopic surgical task performance
Time frame: 4 hours
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 2020.
- 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.
Magdy Milad, MD principal investigator
Northwestern University
Emily Lin, MD study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Simulation Training in people with Educational Problems, run by Northwestern University 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 3 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: finished, as of the sponsor's last update on 24 Aug 2020. 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?
Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2020.