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OpenTrials
Completed

NCT Number: NCT00318279

Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kelman Advanced Centre for Learning, The University of Western Ontario

London, Ontario, N6A, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical simulator to practice vascular anastomosis

Device

Primary outcomes

  1. Quality of final vascular anastomosis based on validated scale

Secondary outcomes

  1. Global rating of operative skill based on validated scale (final anastomosis)

  2. Time taken to complete final anastomosis

  3. Time taken to complete initial and final anastomosis (experimental group only)

  4. Anastomotic leakage for final anastomosis

  5. Anastomotic patency for final anastomosis

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 26, 2006
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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