Developing a Curriculum to Teach Laparoscopic Colorectal Surgery
16. november 2015 opdateret af: Teodor Grantcharov, Unity Health Toronto
Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum.
The purpose of this study is to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery.
This curriculum will include training on a virtual reality simulator, cognitive training and cadaver lab training.
The investigators will assess the effectiveness of the curriculum by conducting a randomized single blinded controlled trial.
The investigators will be comparing the technical performance of curricular trained and non-trained residents in the operating room, during a procedure on a patient.
The investigators hypothesize that surgical residents who participate in the curriculum will have superior technical proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery compared to conventionally trained residents.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5R3C3
- St. Michael's Hospital
-
-
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:
- resident in general surgery
- post graduate year (PGY) 2 or higher
- performed less than 10 laparoscopic colorectal procedures independently
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Curricular Trained
Residents in the curricular training group will participate in the entire ex-vivo training curriculum.
They will train to proficiency on a virtual reality simulator.
This training program has 8 tasks at an "easy", "medium" and "hard" level.
They will also participate in a cognitive training component.
This consists of self-directed reading, and a video training component.
In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator.
Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver.
|
Residents in the curricular training group will participate in the entire ex-vivo training curriculum.
They will train to proficiency on a virtual reality simulator.
This training program has 8 tasks at an "easy", "medium" and "hard" level.
They will also participate in a cognitive training component.
This consists of self-directed reading, and a video training component.
In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator.
Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver.
|
|
Ingen indgriben: conventional residency training
These residents proceed through surgical residency training as usual
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in operating room performance between intervention and control group
Tidsramme: 5 months from intervention
|
Surgical residents participating in the study will perform a laparoscopic right colectomy in the operating room.
The procedure will be video-recorded through the laparoscopic camera.
The videos will be given to a blinded expert in video assessment who will assess the technical proficiency of the resident using a validated global rating scale.
|
5 months from intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in cognitive knowledge between intervention and control group
Tidsramme: 5 months from the intervention
|
Residents in both groups will complete a multiple choice test designed to assess the amount of cognitive knowledge they have relating to the technical steps of performing laparoscopic colorectal surgery
|
5 months from the intervention
|
|
Difference in technical performance on the virtual reality simulator between intervention and control group residents
Tidsramme: 5 months from intervention
|
Study participants will complete the easy level of the virtual reality training portion of the curriculum
|
5 months from intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Teodor P Grantcharov, MD, PhD, Unity Health Toronto
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. juni 2010
Primær færdiggørelse (Faktiske)
1. maj 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
8. juni 2011
Først indsendt, der opfyldte QC-kriterier
9. juni 2011
Først opslået (Skøn)
10. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SMH10-059
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 .