- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02234856
Evaluation of Laparoscopic Hysterectomy Simulator
20. února 2019 aktualizováno: Unity Health Toronto
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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
45
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Heidelberglaan
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Utrecht, Heidelberglaan, Holandsko, 3508 GA
- University Medical Center, Utrecht, The Netherlands
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- University of British Columbia, Division of Obstetrics and Gynecology
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Ontario
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Toronto, Ontario, Kanada, M5S 1A8
- University of Toronto Faculty of Medicine
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California
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Los Angeles, California, Spojené státy, 90033
- University of Southern California, Department of Obstetrics and Gynecology
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Los Angeles, California, Spojené státy, 90095
- University of California Los Angeles, Department of Obstetrics and Gynecology
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Washington
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Seattle, Washington, Spojené státy, 98195
- University of Washington, School of Medicine, Department of Obstetrics and Gynecology
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Faculty in the Department of Ob-Gyn
- Experienced OBGYN surgeons
- Residents in the Department of Ob-Gyn
Exclusion Criteria:
- None
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: conventional residency training
no intervention
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Experimentální: Laparoscopic Hysterectomy trainer
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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of residents using validation tool
Časové okno: 7-10 days
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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.
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7-10 days
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of experts using validation tool
Časové okno: 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.
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7-10 days
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Dr. Satkunaratnam Abheha, MD, Unity Health Toronto
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. července 2014
Primární dokončení (Aktuální)
1. července 2018
Dokončení studie (Aktuální)
1. července 2018
Termíny zápisu do studia
První předloženo
6. srpna 2014
První předloženo, které splnilo kritéria kontroly kvality
4. září 2014
První zveřejněno (Odhad)
9. září 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. února 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. února 2019
Naposledy ověřeno
1. února 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 30509
Plán pro data jednotlivých účastníků (IPD)
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