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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560494
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention
Surgical Education Other: STAC curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome 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 Outcome 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.


Enrollment: 20
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STAC curriculum 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.
No Intervention: Conventional 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • post graduate year 1 and 2 general surgical residents
  • completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560494


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Teodor Grantcharov, MD, PhD St. Michael's Hospital, Toronto
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01560494     History of Changes
Other Study ID Numbers: STAC
First Submitted: March 13, 2012
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
Last Verified: March 2012