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Clinical Trials/NCT01560494
NCT01560494CompletedNot Applicable

Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study

Unity Health Toronto2 sites in 1 country20 target enrollmentStarted: July 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Technical skills

Study Overview

Brief Summary

This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.

Detailed Description

The objective of this study was to develop and validate an ex-vivo comprehensive curriculum for a basic laparoscopic procedure. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex-vivo training on learning curves in the operating room (OR), nor the effect on non-technical proficiency has been investigated. This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured-curriculum (STAC) group or conventional residency training. The STAC curriculum consisted of: case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to: learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and non-technical skills.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • post graduate year 1 and 2 general surgical residents
  • completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Technical skills

Time Frame: 6 months

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)

Secondary Outcomes

  • cognitive knowledge(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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