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Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

This study is not yet open for participant recruitment.
Verified by Lawson Health Research Institute, April 2006

Sponsored by: Lawson Health Research Institute
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00318279
  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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

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 of Results:

Other Publications:
Grober ED, Hamstra SJ, Wanzel KR, Reznick RK, Matsumoto ED, Sidhu RS, Jarvi KA. The educational impact of bench model fidelity on the acquisition of technical skill: the use of clinically relevant outcome measures. Ann Surg. 2004 Aug;240(2):374-81.
 
Grober ED, Hamstra SJ, Wanzel KR, Reznick RK, Matsumoto ED, Sidhu RS, Jarvi KA. Laboratory based training in urological microsurgery with bench model simulators: a randomized controlled trial evaluating the durability of technical skill. J Urol. 2004 Jul;172(1):378-81.
 
Anastakis DJ, Regehr G, Reznick RK, Cusimano M, Murnaghan J, Brown M, Hutchison C. Assessment of technical skills transfer from the bench training model to the human model. Am J Surg. 1999 Feb;177(2):167-70.
 
Hance J, Aggarwal R, Stanbridge R, Blauth C, Munz Y, Darzi A, Pepper J. Objective assessment of technical skills in cardiac surgery. Eur J Cardiothorac Surg. 2005 Jul;28(1):157-62. Epub 2005 Apr 9.
 
Watterson JD, Beiko DT, Kuan JK, Denstedt JD. Randomized prospective blinded study validating acquistion of ureteroscopy skills using computer based virtual reality endourological simulator. J Urol. 2002 Nov;168(5):1928-32.
 
Reznick R, Regehr G, MacRae H, Martin J, McCulloch W. Testing technical skill via an innovative "bench station" examination. Am J Surg. 1997 Mar;173(3):226-30.
 
Youngblood PL, Srivastava S, Curet M, Heinrichs WL, Dev P, Wren SM. Comparison of training on two laparoscopic simulators and assessment of skills transfer to surgical performance. J Am Coll Surg. 2005 Apr;200(4):546-51.
 
Beard JD, Jolly BC, Newble DI, Thomas WE, Donnelly J, Southgate LJ. Assessing the technical skills of surgical trainees. Br J Surg. 2005 Jun;92(6):778-82.
 
Clark JA, Volchok JA, Hazey JW, Sadighi PJ, Fanelli RD. Initial experience using an endoscopic simulator to train surgical residents in flexible endoscopy in a community medical center residency program. Curr Surg. 2005 Jan-Feb;62(1):59-63.
 
Backstein D, Agnidis Z, Sadhu R, MacRae H. Effectiveness of repeated video feedback in the acquisition of a surgical technical skill. Can J Surg. 2005 Jun;48(3):195-200.
 

Study ID Numbers:   R-05-826, PSI#06-09
First Received:   April 24, 2006
Last Updated:   April 24, 2006
ClinicalTrials.gov Identifier:   NCT00318279
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 October 06, 2008




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