NCT01560494

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 13, 2012

Last Update Submit

March 20, 2012

Conditions

Surgical Education

Outcome Measures

Primary Outcomes (1)

  • Technical skills

    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)

    6 months

Secondary Outcomes (1)

  • cognitive knowledge

    6 months

Study Arms (2)

STAC curriculum

EXPERIMENTAL
Other: STAC curriculum

Conventional Curriculum

NO INTERVENTION

Interventions

STAC curriculumOTHER

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

STAC curriculum

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23013806DERIVED

Study Officials

  • Teodor Grantcharov, MD, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 22, 2012

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

CA(1)