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Effect of Validated Skills Simulation With the Miya Model

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05418764
Enrollment
25
Registered
2022-06-14
Start date
2021-12-27
Completion date
2025-10-13
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Hysterectomy

Keywords

vaginal surgery techniques, gynecological procedures, mid-urethral slings (MUS), simulation training

Brief 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.

Detailed 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.

Interventions

OTHERMiyamodel Training

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Participants will perform 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 - o Residents in the simulation arm will train until they reach a score of 27 on the modified Vagina Surgical Skills Index (VSSI)

Intervention model description

Study participants will be residents at participating institutions who agree to participate in the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vaginal Surgical Skills Index (VSSI) scores - Control GroupMonth 2compare 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
Vaginal Surgical Skills Index (VSSI) scores - Intervention GroupMonth 2compare 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLeslie Kammire, MD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026