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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01560494
First received: March 13, 2012
Last updated: March 20, 2012
Last verified: March 2012

March 13, 2012
March 20, 2012
July 2008
July 2009   (final data collection date for primary outcome measure)
Technical skills [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01560494 on ClinicalTrials.gov Archive Site
cognitive knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Study participants will complete a multiple choice quiz designed to assess congitive knowledge relating to performing laparoscpoic cholecystectomy.
Same as current
Not Provided
Not Provided
 
Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery
Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Surgical Education
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.
  • Experimental: STAC curriculum
    Intervention: Other: STAC curriculum
  • No Intervention: Conventional Curriculum
Palter VN, Orzech N, Reznick RK, Grantcharov TP. Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial. Ann Surg. 2013 Feb;257(2):224-30. doi: 10.1097/SLA.0b013e31827051cd.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2010
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • post graduate year 1 and 2 general surgical residents
  • completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01560494
STAC
No
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Not Provided
Principal Investigator: Teodor Grantcharov, MD, PhD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP