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Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Lawson Health Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318279
First received: April 24, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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 Intervention
Education, Medical
Device: Surgical simulator to practice vascular anastomosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Benefits of a Surgical Skills Lab Vascular Anastomosis Simulator: A Randomized Controlled Trial

Further study details as provided by Lawson Health Research Institute:

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

Estimated Enrollment: 40
Study Start Date: May 2006
Estimated Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00318279     History of Changes
Other Study ID Numbers: R-05-826, PSI#06-09
Study First Received: April 24, 2006
Last Updated: April 24, 2006
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 25, 2014