- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02234856
Evaluation of Laparoscopic Hysterectomy Simulator
20. februar 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
45
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia, Division of Obstetrics and Gynecology
-
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Ontario
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Toronto, Ontario, Canada, M5S 1A8
- University of Toronto Faculty of Medicine
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-
-
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California
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Los Angeles, California, Forente stater, 90033
- University of Southern California, Department of Obstetrics and Gynecology
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Los Angeles, California, Forente stater, 90095
- University of California Los Angeles, Department of Obstetrics and Gynecology
-
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington, School of Medicine, Department of Obstetrics and Gynecology
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-
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Heidelberglaan
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Utrecht, Heidelberglaan, Nederland, 3508 GA
- University Medical Center, Utrecht, The Netherlands
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Faculty in the Department of Ob-Gyn
- Experienced OBGYN surgeons
- Residents in the Department of Ob-Gyn
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: conventional residency training
no intervention
|
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of residents using validation tool
Tidsramme: 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.
|
7-10 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of experts using validation tool
Tidsramme: 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.
|
7-10 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dr. Satkunaratnam Abheha, MD, Unity Health Toronto
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2014
Primær fullføring (Faktiske)
1. juli 2018
Studiet fullført (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først innsendt
6. august 2014
Først innsendt som oppfylte QC-kriteriene
4. september 2014
Først lagt ut (Anslag)
9. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 30509
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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