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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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

Other trials in Canada

Netherlands1 site
  • University Medical Center, Utrecht, The Netherlands

    Utrecht, Heidelberglaan, 3508 GA

Other trials in Netherlands

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 groups in NCT02234856
Study groupRoleWhat they receive
conventional residency trainingNo interventionno intervention
Laparoscopic Hysterectomy trainerExperimentalIntervention: 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.

  1. 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)
  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.

  1. First posted9 Sep 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

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)
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

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.

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