Effect of Validated Skills Simulation With the Miya Model

NCT05418764 | Completed DMC

• 1 other identifier: IRB00072056
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Hysterectomy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The training will be whatever is standard at their Institution

Interventions

Miyamodel Training OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• residents at participating Institutions
• residents have performed ten or fewer vaginal hysterectomies

You may not qualify if:

• having had prior training dedicated to vaginal hysterectomy
• having performed eleven or more vaginal hysterectomies in the OR

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Leslie Kammire, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: December 27, 2021
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: April 1, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)