Comprehensive Laparoscopic Curriculum for Medical Students
Introduction of a Comprehensive Training Curriculum in Laparoscopic Surgery for Medical Students: a Randomized Trial.
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedNovember 17, 2015
November 1, 2015
2 months
May 15, 2013
November 16, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Cognitive Knowledge
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.
1 week
Team-based (non-technical) skills
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).
1 week
Technical Skills
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.
5 weeks
Study Arms (2)
Curriculum
EXPERIMENTALParticipants 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.
Self-directed
NO INTERVENTIONParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- first and second year medical students
You may not qualify if:
- previous exposure to laparoscopy or laparoscopic simulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Toronto
Toronto, Ontario, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2013
First Posted
May 20, 2013
Study Start
June 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 17, 2015
Record last verified: 2015-11