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Completed

NCT Number: NCT05418764

Effect of Validated Skills Simulation With the Miya Model

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.

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Key information

Conditions

Vaginal Hysterectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Miyamodel Training

Other

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

Primary outcomes

  1. Vaginal Surgical Skills Index (VSSI) scores - Control Group

    Time frame: Month 2

    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

  2. Vaginal Surgical Skills Index (VSSI) scores - Intervention Group

    Time frame: Month 2

    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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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