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

NCT ID: NCT01560494

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Surgical Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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STAC curriculum

Group Type EXPERIMENTAL

STAC curriculum

Intervention Type OTHER

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

Conventional Curriculum

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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STAC curriculum

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teodor Grantcharov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23013806 (View on PubMed)

Other Identifiers

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STAC

Identifier Type: -

Identifier Source: org_study_id

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