Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

NCT ID: NCT00318279

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Education, Medical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Interventions

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Surgical simulator to practice vascular anastomosis

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Mackenzie A Quantz, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The University of Western Ontario

Pavan K Koka, BSc, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Ontario

Locations

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Kelman Advanced Centre for Learning, The University of Western Ontario

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 15273564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15201815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10204564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15982599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12394678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9124632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15804468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15810048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15708148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16013622 (View on PubMed)

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.

Reference Type RESULT
PMID: 7273794 (View on PubMed)

Other Identifiers

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11858E

Identifier Type: -

Identifier Source: secondary_id

R-05-826

Identifier Type: -

Identifier Source: org_study_id

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