- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02234856
Evaluation of Laparoscopic Hysterectomy Simulator
20. februar 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia, Division of Obstetrics and Gynecology
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1A8
- University of Toronto Faculty of Medicine
-
-
-
-
California
-
Los Angeles, California, Forenede Stater, 90033
- University of Southern California, Department of Obstetrics and Gynecology
-
Los Angeles, California, Forenede Stater, 90095
- University of California Los Angeles, Department of Obstetrics and Gynecology
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington, School of Medicine, Department of Obstetrics and Gynecology
-
-
-
-
Heidelberglaan
-
Utrecht, Heidelberglaan, Holland, 3508 GA
- University Medical Center, Utrecht, The Netherlands
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: conventional residency training
no intervention
|
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dr. Satkunaratnam Abheha, MD, Unity Health Toronto
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2014
Primær færdiggørelse (Faktiske)
1. juli 2018
Studieafslutning (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først indsendt
6. august 2014
Først indsendt, der opfyldte QC-kriterier
4. september 2014
Først opslået (Skøn)
9. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 30509
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Laparoscopic Hysterectomy trainer
-
ARKSurgicalUkendt
-
The Miriam HospitalBrown UniversityUkendtTræthed | KræftoverlevelseForenede Stater
-
Oregon Health and Science UniversityAfsluttet
-
National Cheng-Kung University HospitalAfsluttet
-
Air Force Military Medical University, ChinaAfsluttetPostoperative komplikationerKina
-
University Hospital of FerraraAfsluttetKirurgi | Rektal prolaps | Afføringsforstyrrelse | Rectocele; KvindeItalien
-
Johns Hopkins UniversityAfsluttetKirurgisk simuleringsuddannelse
-
Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); University of PennsylvaniaAfsluttetAngstlidelserForenede Stater
-
Singapore General HospitalUkendt
-
Inonu UniversityAfsluttetLevertransplantation | Sarkopeni | Sarkopeni ved levercirrhoseTyrkiet (Türkiye)