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Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

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ClinicalTrials.gov Identifier: NCT00318279
Recruitment Status : Unknown
Verified April 2006 by Lawson Health Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : April 26, 2006
Last Update Posted : August 25, 2017
Sponsor:
Information provided by:
Lawson Health Research Institute

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : May 2006
Study Completion Date : September 2007



Primary Outcome Measures :
  1. Quality of final vascular anastomosis based on validated scale

Secondary Outcome Measures :
  1. Global rating of operative skill based on validated scale (final anastomosis)
  2. Time taken to complete final anastomosis
  3. Time taken to complete initial and final anastomosis (experimental group only)
  4. Anastomotic leakage for final anastomosis
  5. Anastomotic patency for final anastomosis


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT00318279


Contacts
Contact: Mackenzie A Quantz, MD, FRCSC (519) 685-8500 ext 33144 maquantz@uwo.ca
Contact: Pavan K Koka, BSc, MD (519) 636-7990 hkoka@uwo.ca

Locations
Canada, Ontario
Kelman Advanced Centre for Learning, The University of Western Ontario Not yet recruiting
London, Ontario, Canada, N6A
Contact: Mackenzie A Quantz, MD, FRCSC    (519) 685-8500 ext 33144    maquantz@uwo.ca   
Principal Investigator: Mackenzie A Quantz, MD, FRCSC         
Principal Investigator: Pavan K Koka, BSc, MD         
Sub-Investigator: Gordon Campbell, BSc,MSc,PhD         
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

Publications of Results:
Other Publications:

Responsible Party: Dr. M. Quantz, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00318279     History of Changes
Other Study ID Numbers: R-05-826
11858E
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: April 2006

Keywords provided by Lawson Health Research Institute:
Surgical education
Vascular anastomosis
Simulator
Randomized controlled trial