Effect of Validated Skills Simulation With the Miya Model

Study Overview
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Brief Summary
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Simulation training with the Miya Model will improve Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons and this phase of the study is designed to test that.

Detailed Description
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Vaginal Hysterectomy (VH) is the desired hysterectomy technique of The American College of Obstetricians and Gynecologists (ACOG) since it is associated with less morbidity, quicker recovery and lower costs than laparoscopic and abdominal hysterectomy. Despite its well documented advantages, numbers nationwide in the US are declining. Of all minimally invasive hysterectomy procedures, the vaginal approach has been the only one demonstrating a consistent decrease in use from 25% of cases in 1998 to 17% of cases in 2010. A large part of this is due to inadequate training for this technique. There currently is no standardized curriculum for teaching VH, and training varies widely between residency programs. It is widely held that simulation training for surgical procedures improves outcome, but there is a need to validate this for vaginal surgery training.

Official Title
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Effect of Validated Skills Simulation With the Miya Model on Operating Room Performance of Vaginal Hysterectomy

Conditions
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Vaginal Hysterectomy

Intervention / Treatment
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* Other: Miyamodel Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: residents at participating Institutions residents have performed two or fewer vaginal hysterectomies Exclusion Criteria: having had prior training dedicated to vaginal hysterectomy having performed three or more vaginal hysterectomies in the OR

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants will be residents at participating institutions who agree to participate in the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive standardized training by performing five hysterectomies on the Miya Model with a trainer who is a sub-PI at each Institution, with each of these training sessions filmed and then scored by blinded experts - Residents in the simulation arm will train until they reach a score of 27 on the modified Vagina Surgical Skills Index (VSSI) | Other: Miyamodel Training<br>* standardized training by performing five hysterectomies on the Miyamodel with a trainer who is a sub-PI at each institution<br>|
| No Intervention: Control group<br>The training will be whatever is standard at their Institution | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Surgical Skills Index (VSSI) scores - Control Group | compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance | Month 2 | 
| Vaginal Surgical Skills Index (VSSI) scores - Intervention Group | compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance | Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal surgery techniques, gynecological procedures, mid-urethral slings (MUS), simulation training