NCT01857180

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

May 15, 2013

Last Update Submit

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

EXPERIMENTAL

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.

Other: Curriculum

Self-directed

NO INTERVENTION

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.

Interventions

Curriculum

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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

Locations