Clinical trial NCT00318279: Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis
Official title: Benefits of a Surgical Skills Lab Vascular Anastomosis Simulator: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education, Medical
Keywords: Surgical education
Vascular anastomosis
Simulator
Randomized controlled trial
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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

Primary outcomes:
measure: Quality of final vascular anastomosis based on validated scale
Secondary outcomes:
measure: Global rating of operative skill based on validated scale (final anastomosis)
measure: Time taken to complete final anastomosis
measure: Time taken to complete initial and final anastomosis (experimental group only)
measure: Anastomotic leakage for final anastomosis
measure: Anastomotic patency for final anastomosis
Other outcomes:
Locations:
city: London
country: Canada
facility: Kelman Advanced Centre for Learning, The University of Western Ontario
state: Ontario
Study officials:
affiliation: The University of Western Ontario
name: Mackenzie A Quantz, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Ontario
name: Pavan K Koka, BSc, MD
role: PRINCIPAL_INVESTIGATOR
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