Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00318279

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if practicing an aorto-saphenous vein anastomosis on a low-fidelity surgical simulator allows trainees to produce a higher quality anastomosis in a shorter period of time, than a group that only learns by watching a video.

Condition or Disease	Intervention/Treatment	Phase
Education, Medical	Device: Surgical simulator to practice vascular anastomosis	N/A

Detailed Description

For many years, surgical training has been considered an apprenticeship, where the training experiences of residents, have been in real operative settings on living patients. We propose a study to demonstrate that - a low-fidelity simulation of an aorta-proximal vein graft anastomosis as in heart bypass surgery, using anatomical replicates (a special hydrogel polymer with properties similar to human vascular tissue) - is an effective, low-cost simulator for learning this surgical skill, and will provide the trainee with the ability to perform a better anastomosis in a shorter period of time.

Hypothesis: Practicing an aorto-saphenous vein anastomosis on a low-fidelity surgical simulator will advance the trainees' learning curve. This will allow trainees to produce a higher quality anastomosis in a shorter period of time, than a group that only learns by watching a video and will lead to enhanced patient safety.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Other

Official Title:

Benefits of a Surgical Skills Lab Vascular Anastomosis Simulator: A Randomized Controlled Trial

Actual Study Start Date :

May 1, 2006

Actual Primary Completion Date :

May 1, 2007

Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Quality of final vascular anastomosis based on validated scale []

Secondary Outcome Measures

Global rating of operative skill based on validated scale (final anastomosis) []
Time taken to complete final anastomosis []
Time taken to complete initial and final anastomosis (experimental group only) []
Anastomotic leakage for final anastomosis []
Anastomotic patency for final anastomosis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1st year surgical resident at The University of Western Ontario
Anastomosis naive - the subject must not have performed a human vascular anastomosis in the past (it is acceptable if they have observed one being performed in the past)

Exclusion Criteria:

Completed a human vascular anastomosis as the primary operator/surgeon in the past

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kelman Advanced Centre for Learning, The University of Western Ontario	London	Ontario	Canada	N6A

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator: Mackenzie A Quantz, MD, FRCSC, University of Western Ontario, Canada
Principal Investigator: Pavan K Koka, BSc, MD, University of Western Ontario, Canada