Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2009

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.

Interventions

  • Other: STAC curriculum
    • The STAC curriculum consists of theoretical preparation, case-based learning, proficiency-based virtual reality training, laparoscopic box training, and operating room participation.

Arms, Groups and Cohorts

  • Experimental: STAC curriculum
  • No Intervention: Conventional Curriculum

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • cognitive knowledge
    • Time Frame: 6 months
    • Study participants will complete a multiple choice quiz designed to assess congitive knowledge relating to performing laparoscpoic cholecystectomy.

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Unity Health Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Teodor Grantcharov, MD, PhD, Principal Investigator, Unity Health Toronto

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