Educational ProblemsNCT03360357
Laparoscopic Vaginal Cuff Suturing Profienciency for OBGYN Residents
A study testing Guided drills in people with Educational Problems, run by Mayo Clinic.
Trial summary
A recent survey of obstetrics and gynecology fellowship program directors showed that graduating OB/GYN residents may be underprepared for advanced laparoscopic training, necessitating an evaluation of the current structure of resident and fellow curriculum. 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?
- Guided drills
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 Sep 2020
- 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 OBGYN residents, fellows, and faculty at ACGME accredited residencies in the United States
Who cannot join
- - Non-current OBGYN residents at at ACGME accredited residencies in the United States
About this study
Official title: Laparoscopic Vaginal Cuff Suturing Proficiency Following Two Standard Educational Approaches: A Randomized Controlled Trial
A recent survey of obstetrics and gynecology fellowship program directors showed that graduating OB/GYN residents may be underprepared for advanced laparoscopic training, necessitating an evaluation of the current structure of resident and fellow curriculum. Specifically, only 46% of first year fellows were able to independently perform an abdominal hysterectomy. Out of 28 residents tested using a previously validated laparoscopic cuff suturing model, only 8 (28.6%) passed the assessment.
For this reason, it is necessary to identify the most effective and efficient educational approaches to obtain procedural proficiency. Time and effort has been placed in developing simulation programs. Simulation has shown promising outcomes in improving the performance of trainees and attending physicians with the ultimate objective of generating better surgeons. A previous meta-analysis of simulation-based educational assessments demonstrated that these assessments correlate positively with patient-related outcomes. However, there are limited studies with adequate validity to use simulation for summative evaluations of performance for gynecology residents. The widely used Fundamentals of Laparoscopic Surgery (FLS) program is used for credentialing of general surgeons, however, a systematic review suggested that more validity evidence is required to support its content (selection of tasks and scoring rubric) and the consequences (favorable and unfavorable impact) assessment. Although there has been an increase in the number of models available to teach OB/GYN common gynecologic procedures, there is a lack of evidence to support that these methods are actually allowing residents to create better surgical skills.
To address the current limitations in OB/GYN training, the investigators have developed short, guided drills that cover the steps required for laparoscopic suturing and allow residents opportunities for deliberate practice. These drills will be tested compared to residents watching a laparoscopic suturing video and practicing using a high fidelity, suturing simulation model. Both of these methods are standard educational approaches for teaching laparoscopic skills, but it is unknown if one of the approaches is more effective than the other.
Read the detailed description
Methods: Describe, in detail, the research activities that will be conducted under this protocol:
This study is a randomized controlled trial comparing laparoscopic suturing skills, specifically vaginal cuff closure, of OBGYN residents, fellows, and faculty using two different teaching methods and evaluate if there is any significant difference in their performance after teaching with the two different educational approaches. The laparoscopic camera/scope within a box trainer will video record the drills and the cuff suturing evaluation anonymously. These anonymous videos will be used to set proficiency standards for the drills and evaluate which educational approach is most effective.
The educational video and high fidelity simulation practice group will watch a 10 minute educational video on how to suture laparoscopically and then practice using a high fidelity simulation model for 15 minutes.
The second group is going to consist of "guided drills" as their laparoscopic training for 15 minutes. The residents will perform 5 set of exercises:
- "Needle Dance" (Learning to manipulate the suture)
- "Loopy Loop" (Learning to place needle through a loop)
- "Slalom Course" (Passing the needle and suture through 5 rings right handed and left handed)
- "Dense Matter" (Passing the needle through dense material without losing control of the needle)
- "Respect for tissue" (Passing the needle through flimsy material without tearing)
After these exercises have been completed the participants will proceed to the 5 minute laparoscopic suturing evaluation. The evaluation will consist of closing the vaginal cuff in a previously validated simulator. The residents will have a determined amount of time to complete this task and the laparoscopic suturing will be filmed anonymously. Once the encounter is finished, the video will be saved, reviewed and graded using the previously validated global operative assessment of laparoscopic skills (GOALS).
- needle handling,
- getting the needle into the loop
- vaginal mucosa incorporation
- depth perception
- bimanual dexterity
- efficiency
- tissue handling
- Autonomy. Each area will consist of a score between 1 and 5. The "passing score" that defines proficiency will be 32 points as this number has been related to advance novice-expert in the past.
- Conditions
- Educational Problems
- Being tested
- Guided drills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided drillsProcedure or surgery
These residents will perform 5 set of exercises:
- "Needle Dance" (Learning to manipulate the suture)
- "Loopy Loop" (Learning to place needle through a loop)
- "Slalom Course" (Passing the needle and suture through 5 rings right handed and left handed)
- "Dense Matter" (Passing the needle through dense material without losing control of the needle)
- "Respect for tissue" (Passing the needle through flimsy material without tearing)
| Study group | Role | What they receive |
|---|---|---|
| guided drills | Experimental | These people will be going through all the guided drills before being evaluated. Receives: Procedure: Guided drills |
| Self-trained | No intervention | These people will watch a video and be able to practice by themselves without having any direction regarding how and what to practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proficiency of laparoscopic suturing of OBGYN residents
Vaginal cuff suturing proficiency will be higher in OB/GYN residents assigned to guided laparoscopic drills compared to residents assigned to an education video and high fidelity vaginal cuff suturing simulation model.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Sep 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Why it stopped: Lack of participants to enroll.
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 Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher C. Destephano, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360357
- Sponsor's protocol ID
- 17-008825
- Status last verified
- Apr 2020
- First submitted
- 6 Nov 2017
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Vaginal Cuff Suturing Proficiency Following Two Standard Educational Approaches: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03360357
- Acronym / sponsor ID
- 17-008825
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participants to enroll.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 4 Dec 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.
A recent survey of obstetrics and gynecology fellowship program directors showed that graduating OB/GYN residents may be underprepared for advanced laparoscopic training, necessitating an evaluation of the current structure of resident and fellow curriculum. Specifically, only 46% of first year fellows were able to independently perform an abdominal hysterectomy. Out of 28 residents tested using a previously validated laparoscopic cuff suturing model, only 8 (28.6%) passed the assessment.
For this reason, it is necessary to identify the most effective and efficient educational approaches to obtain procedural proficiency. Time and effort has been placed in developing simulation programs. Simulation has shown promising outcomes in improving the performance of trainees and attending physicians with the ultimate objective of generating better surgeons. A previous meta-analysis of simulation-based educational assessments demonstrated that these assessments correlate positively with patient-related outcomes. However, there are limited studies with adequate validity to use simulation for summative evaluations of performance for gynecology residents. The widely used Fundamentals of Laparoscopic Surgery (FLS) program is used for credentialing of general surgeons, however, a systematic review suggested that more validity evidence is required to support its content (selection of tasks and scoring rubric) and the consequences (favorable and unfavorable impact) assessment. Although there has been an increase in the number of models available to teach OB/GYN common gynecologic procedures, there is a lack of evidence to support that these methods are actually allowing residents to create better surgical skills.
To address the current limitations in OB/GYN training, the investigators have developed short, guided drills that cover the steps required for laparoscopic suturing and allow residents opportunities for deliberate practice. These drills will be tested compared to residents watching a laparoscopic suturing video and practicing using a high fidelity, suturing simulation model. Both of these methods are standard educational approaches for teaching laparoscopic skills, but it is unknown if one of the approaches is more effective than the other.
Detailed description
Methods: Describe, in detail, the research activities that will be conducted under this protocol:
This study is a randomized controlled trial comparing laparoscopic suturing skills, specifically vaginal cuff closure, of OBGYN residents, fellows, and faculty using two different teaching methods and evaluate if there is any significant difference in their performance after teaching with the two different educational approaches. The laparoscopic camera/scope within a box trainer will video record the drills and the cuff suturing evaluation anonymously. These anonymous videos will be used to set proficiency standards for the drills and evaluate which educational approach is most effective.
The educational video and high fidelity simulation practice group will watch a 10 minute educational video on how to suture laparoscopically and then practice using a high fidelity simulation model for 15 minutes.
The second group is going to consist of "guided drills" as their laparoscopic training for 15 minutes. The residents will perform 5 set of exercises:
- "Needle Dance" (Learning to manipulate the suture)
- "Loopy Loop" (Learning to place needle through a loop)
- "Slalom Course" (Passing the needle and suture through 5 rings right handed and left handed)
- "Dense Matter" (Passing the needle through dense material without losing control of the needle)
- "Respect for tissue" (Passing the needle through flimsy material without tearing)
After these exercises have been completed the participants will proceed to the 5 minute laparoscopic suturing evaluation. The evaluation will consist of closing the vaginal cuff in a previously validated simulator. The residents will have a determined amount of time to complete this task and the laparoscopic suturing will be filmed anonymously. Once the encounter is finished, the video will be saved, reviewed and graded using the previously validated global operative assessment of laparoscopic skills (GOALS).
- needle handling,
- getting the needle into the loop
- vaginal mucosa incorporation
- depth perception
- bimanual dexterity
- efficiency
- tissue handling
- Autonomy. Each area will consist of a score between 1 and 5. The "passing score" that defines proficiency will be 32 points as this number has been related to advance novice-expert in the past.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided drills | Experimental | Procedure: Guided drillsThese people will be going through all the guided drills before being evaluated. |
| Self-trained | No intervention | –These people will watch a video and be able to practice by themselves without having any direction regarding how and what to practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current OBGYN residents, fellows, and faculty at ACGME accredited residencies in the United States
Key exclusion criteria (1 listed)
- - Non-current OBGYN residents at at ACGME accredited residencies in the United States
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 |
|---|---|---|
| Guided drillsThese residents will perform 5 set of exercises: 1. "Needle Dance" (Learning to manipulate the suture) 2. "Loopy Loop" (Learning to place needle through a loop) 3. "Slalom Course" (Passing the needle and suture through 5 rings right handed and left handed) 4. "Dense Matter" (Passing the needle through dense material without losing control of the needle) 5. "Respect for tissue" (Passing the needle through flimsy material without tearing) | Procedure or surgery | guided drills |
Primary outcome
Proficiency of laparoscopic suturing of OBGYN residents
Time frame: 15 minutes
Vaginal cuff suturing proficiency will be higher in OB/GYN residents assigned to guided laparoscopic drills compared to residents assigned to an education video and high fidelity vaginal cuff suturing simulation model.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Educational Problems
Not yet recruiting
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Educational Problems, Surgery
Active, not recruiting
Impact of Surgical Coaching on Resident ObGyn Laparoscopic Skills
Educational Problems
Not yet recruiting
Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes
Sleep Problems, Psychological
Active, not recruiting
Fostering Healthy Futures for Teens: An RCT
Child Abuse, Child Neglect
Recruiting
Health Equity and Rural Education (HERE!) Clinical Trial
Behavioral Symptoms, Community Health Workers
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Guided drills in people with Educational Problems, run by Mayo Clinic.
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: withdrawn, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 laparoscopic suturing of OBGYN residents (time frame: 15 minutes). 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 13 Apr 2020.