Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

Education, Medical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318279
• Other study ID #: R-05-826
• Secondary ID: 11858E
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: September 2007

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Education, Medical

Intervention

Device:
• Surgical simulator to practice vascular anastomosis

Locations

Country	Name	City	State
Canada	Kelman Advanced Centre for Learning, The University of Western Ontario	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of final vascular anastomosis based on validated scale
Secondary	Global rating of operative skill based on validated scale (final anastomosis)
Secondary	Time taken to complete final anastomosis
Secondary	Time taken to complete initial and final anastomosis (experimental group only)
Secondary	Anastomotic leakage for final anastomosis
Secondary	Anastomotic patency for final anastomosis