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Effect of Validated Skills Simulation With the Miya Model

NCT ID: NCT05418764

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-27

Study Completion Date

2026-01-31

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.

Conditions

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Vaginal Hysterectomy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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)

Study Groups

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Intervention group

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)

Group Type EXPERIMENTAL

Miyamodel Training

Intervention Type OTHER

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

Control group

The training will be whatever is standard at their Institution

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Miyamodel Training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Kammire, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Noah Miyazaki

Role: CONTACT

Phone: 336.409.2805

Email: [email protected]

Douglas Miyazaki

Role: CONTACT

Phone: 336.414.2462

Email: [email protected]

Facility Contacts

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Noah Miyazaki

Role: primary

Other Identifiers

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IRB00072056

Identifier Type: -

Identifier Source: org_study_id