- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01857180
Comprehensive Laparoscopic Curriculum for Medical Students
Introduction of a Comprehensive Training Curriculum in Laparoscopic Surgery for Medical Students: a Randomized Trial.
Laparoscopic surgery has become the standard approach to a vast variety of surgical procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation, amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a different set of skills than in open access surgery. Acknowledging this, several comprehensive curricula have been developed to teach basic skills as well as advanced laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to surgery no designated curricula have been developed to introduce medical students to the technique of laparoscopic surgery.
Participation in an introductory curriculum in laparoscopic surgery results in improved cognitive and technical performance compared to self-directed learning. The greater homogeneity and fewer dropouts amongst those in the curriculum group suggest that a structured curriculum is essential in ensuring standardization of clinically relevant training. An introductory curriculum for medical students should be delivered in a structured and standardized fashion prior to clinical exposure in order to maintain motivation and enhance learning.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada
- Univeristy of Toronto
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- first and second year medical students
Exclusion Criteria:
- previous exposure to laparoscopy or laparoscopic simulation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Curriculum
Participants in the curriculum group took part in a structured, comprehensive curriculum consisting of a 1 hour didactic cognitive component, a 1 hour didactic non-technical (team-based skills) component, and 6 hours of structured technical skills practice in peg transfer, intracorporeal suture, and VR simulator tasks.
Participants had the opportunity to ask questions and engage in discussion with experts after the didactic sessions, and received subjective feedback from circulating residents in addition to objective feedback in the technical skills tasks.
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Nessun intervento: Self-directed
Participants in the control (self-directed) group took part in 8 hours of self-directed learning with written materials for cognitive and non-technical skills components and unstructured surgical simulation practice of technical skills with only objective feedback from the simulator for the VR tasks or time for the peg transfer and intracorporeal suture tasks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cognitive Knowledge
Lasso di tempo: 1 week
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Participants' basic laparoscopic knowledge was assessed regarding topics such as advantages and disadvantages, patient selection considerations, equipment, anesthesia, patient positioning, pneumoperitoneum, and post-op care.
Assessment was by a multiple choice test.
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1 week
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Team-based (non-technical) skills
Lasso di tempo: 1 week
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Participants' attitudes towards team based skills, namely team structure, leadership, situational awareness, and communication were assessed by the Team-STEPPS Teamwork Attitudes Questionnaire (T-TAQ).
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1 week
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Technical Skills
Lasso di tempo: 5 weeks
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Participants' technical skills were assessed as they performed peg transfer, intracorporeal suture, and virtual reality simulator tasks (grasping, cutting, and clipping).
Peg transfer and intracorporeal suture were assessed by time and errors, while VR tasks were assessed by the simulator's pre-set metrics.
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5 weeks
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Med Student Lap Curriculum
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .