Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

NCT00318279 | Completed

• 2 other identifiers: R-05-82611858E
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Education, Medical

Keywords

Surgical education; Vascular anastomosis; Simulator; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Quality of final vascular anastomosis based on validated scale

Secondary Outcomes (5)

• 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

Interventions

Surgical simulator to practice vascular anastomosis DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st 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)

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Kelman Advanced Centre for Learning, The University of Western Ontario

London, Ontario, N6A, Canada

Location

Related Publications (11)

• 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. doi: 10.1097/01.sla.0000133346.07434.30.

  PMID: 15273564 BACKGROUND

• 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. doi: 10.1097/01.ju.0000123824.74075.9c.

  PMID: 15201815 BACKGROUND

• 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. doi: 10.1016/s0002-9610(98)00327-4.

  PMID: 10204564 BACKGROUND

• 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. doi: 10.1016/j.ejcts.2005.03.012. Epub 2005 Apr 9.

  PMID: 15982599 BACKGROUND

• 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. doi: 10.1016/S0022-5347(05)64265-6.

  PMID: 12394678 BACKGROUND

• 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. doi: 10.1016/s0002-9610(97)89597-9.

  PMID: 9124632 BACKGROUND

• 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. doi: 10.1016/j.jamcollsurg.2004.11.011.

  PMID: 15804468 BACKGROUND

• 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. doi: 10.1002/bjs.4951.

  PMID: 15810048 BACKGROUND

• 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. doi: 10.1016/j.cursur.2004.07.002.

  PMID: 15708148 BACKGROUND

• 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.

  PMID: 16013622 BACKGROUND

• Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5.

  PMID: 7273794 RESULT

Study Officials

• Mackenzie A Quantz, MD, FRCSC

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

• Pavan K Koka, BSc, MD

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

CA (1)