Effect of Validated Skills Simulation With the Miya Model

Vaginal Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418764
• Other study ID #: IRB00072056
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2021
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: Noah Miyazaki
• Phone: 336.409.2805
• Email: noahmiyazaki[@]miyazakienterprises.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• residents at participating Institutions

• residents have performed ten or fewer vaginal hysterectomies

Exclusion Criteria:

• having had prior training dedicated to vaginal hysterectomy

• having performed eleven or more vaginal hysterectomies in the OR

Related Conditions & MeSH terms

• Vaginal Hysterectomy

Intervention

Other:
• Miyamodel Training
standardized training by performing five hysterectomies on the Miyamodel with a trainer who is a sub-PI at each institution

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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