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Completed

NCT Number: NCT01560494

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

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.

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Key information

Conditions

Surgical Education

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

STAC curriculum

Other

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

Primary outcomes

  1. 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

  1. cognitive knowledge

    Time frame: 6 months

    Study participants will complete a multiple choice quiz designed to assess congitive knowledge relating to performing laparoscpoic cholecystectomy.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 22, 2012
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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