Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery

Study Overview
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Brief Summary
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The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.

Official Title
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Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery

Conditions
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Simulation for Preparation of Robotic Surgery

Intervention / Treatment
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* Other: Mimic dv-Trainer
* Other: daVinci Skills Simulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training Completion of the online orientation to daVinci Surgical System Exclusion Criteria: Performance of any robotic surgical procedures as the console surgeon Performance of any robotic simulator protocols Any significant amount of time spent on a virtual reality robotic simulator
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mimic dV-Trainer<br> | Other: Mimic dv-Trainer<br> <br> |
| Other: daVinci Skills Simulator<br> | Other: daVinci Skills Simulator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Operative time will be measured by time elapsed between first grasp of the uterine fundus with the robotic single tooth tenaculum until amputation of the specimen at the internal cervical os. | at time of supracervical hysterectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume. | during the surgical procedure | 
| Surgical Skill Rating | As measured by the global assessment tool for evaluation of intraoperative laparoscopic skills (GOALS) tool via video assessment. These ratings will be performed by a group of surgeons who are not involved in the study and are masked as to the identity of the study surgeons. | following completion of the procedure | 
| Continued success with robotic surgery after participation in the study | The number of cases each participating resident performs as primary surgeon the 12 months after completion of the study will be recorded | during the 12 months following surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic surgery, simulation