NCT01753947

Brief Summary

Training on simulated models in a surgical skills laboratory has been shown to improve technical performance in the operating room. Currently described simulation-based curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate to the operating room. This randomized controlled trial effectively demonstrates that deliberate practice on a virtual reality simulator results in an improvement in technical skills in a real clinical situation. This enhances the feasibility of implementing simulation-based curricula into residency training programs, and consequently has the potential to improve patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration 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

January 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

3 years

First QC Date

December 7, 2012

Last Update Submit

December 17, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Technical skills

    Participants' technical skills will be assessed in the operating room as they perform a laparoscopic cholecystectomy under supervision. The procedure will be video-recorded and sent for assessment to a blinded evaluator. Technical skills will be assessed using a previously validated technical skills assessment tool (Objective Structured Assessment of Technical Skill - OSATS)

    6 months

Study Arms (2)

Deliberate Practice

EXPERIMENTAL

Residents in the deliberate practice group received individualized feedback at the end of the initial assessment case. The staff surgeon supervising the case completed 3 previously validated technical skills assessment forms.

Other: Deliberate Practice

Conventional Feedback

NO INTERVENTION

Residents in the control group received informal feedback as they performed the initial laparoscopic cholecystectomy in the operating room. This was left up to the discretion of the staff surgeon supervising the operation. This corresponds to the routine teaching and feedback practices that occur during conventional surgical residency training

Interventions

Deliberate Practice

Eligibility Criteria

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

You may qualify if:

  • post graduate year 1 and 2 surgical residents
  • performed less than 10 laparoscopic cholecystectomies as the primary surgeon

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University 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

December 7, 2012

First Posted

December 20, 2012

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations