Evaluation of Laparoscopic Hysterectomy SimulatorNCT02234856
Evaluation of Laparoscopic Hysterectomy Simulator
A study testing Laparoscopic Hysterectomy trainer in people with Evaluation of Laparoscopic Hysterectomy Simulator, run by Unity Health Toronto at 6 sites in 3 countries.
Trial summary
This study aims to test the validity of a new educational tool in the form of a computer based video surgical simulator, that may be used to enhance the current teaching method of how to perform a hysterectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Evaluation of Laparoscopic Hysterectomy Simulator
- What is being tested?
- Laparoscopic Hysterectomy trainer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jul 2014to Jul 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Faculty in the Department of Ob-Gyn
- Experienced OBGYN surgeons
- Residents in the Department of Ob-Gyn
Who cannot join
- None
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States3 sites
University of Southern California, Department of Obstetrics and Gynecology
Los Angeles, California, 90033
University of California Los Angeles, Department of Obstetrics and Gynecology
Los Angeles, California, 90095
University of Washington, School of Medicine, Department of Obstetrics and Gynecology
Seattle, Washington, 98195
Canada2 sites
University of Toronto Faculty of Medicine
Toronto, Ontario, M5S 1A8
University of British Columbia, Division of Obstetrics and Gynecology
Vancouver, British Columbia, V5Z 1M9
Netherlands1 site
University Medical Center, Utrecht, The Netherlands
Utrecht, Heidelberglaan, 3508 GA
About this study
Official title: Evaluation of Laparoscopic Hysterectomy Simulator to Improve Cognitive Surgical Knowledge of Obstetrics and Gynecology Trainees
This study aims to test the validity of a new educational tool in the form of a computer based video surgical simulator, that may be used to enhance the current teaching method of how to perform a hysterectomy.
Read the detailed description
Ensuring the surgical competence of trainees is mandatory for all surgical residency programs, yet most evaluations of graduating residents are based on observation and subjective feedback. We have developed a computer based video surgical simulator to facilitate cognitive knowledge of the step-by-step process needed to perform a laparoscopic hysterectomy, learn essential pelvic anatomy and avoid surgical complications. Studies have shown that when trainees already have the cognitive knowledge of how to perform a procedure, they can focus more on learning surgical technique and how to minimize surgical complications. Laparoscopy is becoming the standard of surgical care for gynecologic patients. The benefits of minimally invasive surgery include reduced postoperative pain, shorter hospitalization, less scarring, quicker return to normal activities, preservation of immune response, and fewer long-term problems such as adhesions or incisional hernia. The current challenge in surgical education is how to produce competent surgeons who are skilled to perform and integrate the multiple advances in surgical technology. Surgical competency involves proficiency in technical skills, decision-making (preoperative, operative, and postoperative), and team performance all of which require knowledge and communication skills. The increasing complexity of surgery and the requirements for mastery at laparotomy, laparoscopy, and endoscopy reduces the feasibility of the traditional "see one, do one, teach one" model of surgical education. Lack of training is considered a major barrier to performing laparoscopic surgery. Alternative training modalities are required to acquire the necessary surgical skills for laparoscopy. Although there is a transfer of skills and knowledge to the trainee by the time of graduation, current training programs have not been designed in a validated, effective, and competency-based manner. A successful laparoscopic curriculum should incorporate a cognitive component in addition to the manual skills component. Although the benefit of simulators as a method of surgical education has been validated, comprehensive curriculum development is lacking. Most recently, Zevin et al. (2012) conducted a Delphi consensus involving international experts in surgical education on the principles for design, validation and implementation of a simulation-based surgical training curriculum. The main components of the final framework included predevelopment analysis; cognitive, psychomotor, and team-based training; curriculum validation, evaluation, and improvement; and maintenance of training. They have produced a framework that is based on the broad principles of educational theory that can be applied to any surgical specialty. Several authors have emphasized the importance of cognitive teaching in a comprehensive surgical skills training curriculum. Learning begins with the acquisition of procedure-specific knowledge. Categories include pre-procedure assessment and preparation; anatomic knowledge; safety and limitations of specific instruments; ergonomics; and post-procedure management. A cognitive curriculum can include reading materials in the form of text books or journal articles as well as procedural video tutorials. The cognitive component should be studied by the trainee before technical skills training and should be followed by satisfactory performance on a paper-based test of knowledge or a mock operative note dictation. Teaching about errors commonly associated with the procedure should be included so that trainees can anticipate or avoid them in the future, and recognize and manage them if they occur. The purpose of this research study is to test the validity of a new educational tool as an enhancement to the current teaching method of how to perform a hysterectomy. Should our data substantiate our hypothesis, that cognitive function of surgical trainees will be enhanced by use of the trainer, then the tool will be able to be utilized as a new, advanced, creative tool for teaching how to perform a hysterectomy. This tool might then be able to be utilized to advance the teaching of many other surgical procedures to residents in many different surgical programs.
- Being tested
- Laparoscopic Hysterectomy trainer
- Keywords
- Hysterectomy, Laparoscopy, Surgical assessment, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Hysterectomy trainerProcedure or surgery
In order to increase comfort level amongst Gynecologists, we aim to identify verbal and non-verbal components of teaching TLH through interview and video recordings. Utilizing qualitative analysis of common themes, we will develop an educational video and web-based e-module to be used by Gynecology residents and surgeons. We will also use a combination of quantitative pre- and post-tests and qualitative surveys to assess the effectiveness of such a training tool. Ultimately, the project aims to create a robust tool that can be implemented in Gynecology residencies.
| Study group | Role | What they receive |
|---|---|---|
| conventional residency training | No intervention | no intervention |
| Laparoscopic Hysterectomy trainer | Experimental | Intervention: An educational video and web-based e-module will be created. The final product will be reviewed by the expert contributors. Once approved, these tools will be showcased to a voluntary focus group of Obstetrics and Gynecology residents at the University of Toronto. A quantitative assessment of effectiveness of this tool will be performed through the use of pre- and post-tests of knowledge. A qualitative needs assessment will also be performed using post-viewing surveys. If found to be effective, this educational tool will be incorporated in the University of Toronto Obstetrics and Gynecology residency curriculum. Receives: Procedure: Laparoscopic Hysterectomy trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of residents using validation tool
Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a "knowledge curve." Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.
Measured: 7-10 days
Secondary outcomes (1)
Number of experts using validation tool
Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a "knowledge curve." Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Laparoscopic Hysterectomy SimulatorStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Dr. Satkunaratnam Abheha, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234856
- Sponsor's protocol ID
- 30509
- Status last verified
- Feb 2019
- First submitted
- 6 Aug 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laparoscopic Hysterectomy Simulator to Improve Cognitive Surgical Knowledge of Obstetrics and Gynecology Trainees
- ClinicalTrials.gov ID
- NCT02234856
- Acronym / sponsor ID
- 30509
- Keywords
- Hysterectomy, Laparoscopy, Surgical assessment, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 9 Sep 2014 (estimated)
- 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.
This study aims to test the validity of a new educational tool in the form of a computer based video surgical simulator, that may be used to enhance the current teaching method of how to perform a hysterectomy.
Detailed description
Ensuring the surgical competence of trainees is mandatory for all surgical residency programs, yet most evaluations of graduating residents are based on observation and subjective feedback. We have developed a computer based video surgical simulator to facilitate cognitive knowledge of the step-by-step process needed to perform a laparoscopic hysterectomy, learn essential pelvic anatomy and avoid surgical complications. Studies have shown that when trainees already have the cognitive knowledge of how to perform a procedure, they can focus more on learning surgical technique and how to minimize surgical complications. Laparoscopy is becoming the standard of surgical care for gynecologic patients. The benefits of minimally invasive surgery include reduced postoperative pain, shorter hospitalization, less scarring, quicker return to normal activities, preservation of immune response, and fewer long-term problems such as adhesions or incisional hernia. The current challenge in surgical education is how to produce competent surgeons who are skilled to perform and integrate the multiple advances in surgical technology. Surgical competency involves proficiency in technical skills, decision-making (preoperative, operative, and postoperative), and team performance all of which require knowledge and communication skills. The increasing complexity of surgery and the requirements for mastery at laparotomy, laparoscopy, and endoscopy reduces the feasibility of the traditional "see one, do one, teach one" model of surgical education. Lack of training is considered a major barrier to performing laparoscopic surgery. Alternative training modalities are required to acquire the necessary surgical skills for laparoscopy. Although there is a transfer of skills and knowledge to the trainee by the time of graduation, current training programs have not been designed in a validated, effective, and competency-based manner. A successful laparoscopic curriculum should incorporate a cognitive component in addition to the manual skills component. Although the benefit of simulators as a method of surgical education has been validated, comprehensive curriculum development is lacking. Most recently, Zevin et al. (2012) conducted a Delphi consensus involving international experts in surgical education on the principles for design, validation and implementation of a simulation-based surgical training curriculum. The main components of the final framework included predevelopment analysis; cognitive, psychomotor, and team-based training; curriculum validation, evaluation, and improvement; and maintenance of training. They have produced a framework that is based on the broad principles of educational theory that can be applied to any surgical specialty. Several authors have emphasized the importance of cognitive teaching in a comprehensive surgical skills training curriculum. Learning begins with the acquisition of procedure-specific knowledge. Categories include pre-procedure assessment and preparation; anatomic knowledge; safety and limitations of specific instruments; ergonomics; and post-procedure management. A cognitive curriculum can include reading materials in the form of text books or journal articles as well as procedural video tutorials. The cognitive component should be studied by the trainee before technical skills training and should be followed by satisfactory performance on a paper-based test of knowledge or a mock operative note dictation. Teaching about errors commonly associated with the procedure should be included so that trainees can anticipate or avoid them in the future, and recognize and manage them if they occur. The purpose of this research study is to test the validity of a new educational tool as an enhancement to the current teaching method of how to perform a hysterectomy. Should our data substantiate our hypothesis, that cognitive function of surgical trainees will be enhanced by use of the trainer, then the tool will be able to be utilized as a new, advanced, creative tool for teaching how to perform a hysterectomy. This tool might then be able to be utilized to advance the teaching of many other surgical procedures to residents in many different surgical programs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional residency training | No intervention | –no intervention |
| Laparoscopic Hysterectomy trainer | Experimental | Procedure: Laparoscopic Hysterectomy trainerIntervention: An educational video and web-based e-module will be created. The final product will be reviewed by the expert contributors. Once approved, these tools will be showcased to a voluntary focus group of Obstetrics and Gynecology residents at the University of Toronto. A quantitative assessment of effectiveness of this tool will be performed through the use of pre- and post-tests of knowledge. A qualitative needs assessment will also be performed using post-viewing surveys. If found to be effective, this educational tool will be incorporated in the University of Toronto Obstetrics and Gynecology residency curriculum. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Faculty in the Department of Ob-Gyn
- Experienced OBGYN surgeons
- Residents in the Department of Ob-Gyn
Key exclusion criteria (1 listed)
- None
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 Hysterectomy trainerIn order to increase comfort level amongst Gynecologists, we aim to identify verbal and non-verbal components of teaching TLH through interview and video recordings. Utilizing qualitative analysis of common themes, we will develop an educational video and web-based e-module to be used by Gynecology residents and surgeons. We will also use a combination of quantitative pre- and post-tests and qualitative surveys to assess the effectiveness of such a training tool. Ultimately, the project aims to create a robust tool that can be implemented in Gynecology residencies. | Procedure or surgery | Laparoscopic Hysterectomy trainer |
Primary outcome
Number of residents using validation tool
Time frame: 7-10 days
Phase I will consist of two on line tests that assess surgical and anatomic knowledge. The tests will be separated by 7-10 days. Evaluation will determine the validity of the tests as well as creating a "knowledge curve." Analyzing resident and faculty performance with a one-way analysis of variance, with level of training as the independent variable, will assess construct validity. Post hoc contrasts are done with Student-Newman-Keuls test. We will also evaluate the validity of the exam by comparing the performance of novice surgeons with more advanced residents and experts. Internal consistency of the examination, which is a measure of the reliability of the test, will be calculated using Cronbach's alpha test. Results will be presented as percentages, means and standard deviations based on the number of questions that are answered correctly.
1 secondary outcome
Number of experts using validation tool
Time frame: 7-10 days
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 22 Feb 2019.
- Individual participant dataSharing planned: Undecided
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.
Dr. Satkunaratnam Abheha, MD principal investigator
Unity Health Toronto
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Hysterectomy trainer in people with Evaluation of Laparoscopic Hysterectomy Simulator, run by Unity Health Toronto at 6 sites in 3 countries.
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 22 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 6 sites in United States, Canada, Netherlands. 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?
Number of residents using validation tool (time frame: 7-10 days). 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 22 Feb 2019.