70 Participants Needed

Simulation Training for Vaginal Hysterectomy Skills

NM
DM
Overseen ByDouglas Miyazaki
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Miyamodel Training, Miya Model Simulator, Miya Model Training System for vaginal hysterectomy skills?

Research shows that the Miya Model is a realistic simulation tool for training in vaginal hysterectomy, with studies validating its use as an effective way to assess and improve surgical skills.12345

How is the Miyamodel Training for vaginal hysterectomy skills different from other treatments?

The Miyamodel Training is unique because it uses a realistic simulation model to teach and assess vaginal hysterectomy skills, providing a hands-on learning experience without the need for live patients. This approach addresses the decline in opportunities for practical training in vaginal hysterectomy by offering a safe and controlled environment for skill development.12678

What is the purpose of this trial?

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.

Research Team

LK

Leslie Kammire, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for novice surgeons who are residents at participating institutions and have performed two or fewer vaginal hysterectomies. It's not open to those who've had dedicated training in this procedure or have done three or more such surgeries in the operating room.

Inclusion Criteria

I have performed two or fewer vaginal hysterectomies.
Residents at participating Institutions

Exclusion Criteria

I have received training in performing vaginal hysterectomies.
I have performed at least three vaginal hysterectomies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants in the intervention group receive standardized training by performing five hysterectomies on the Miya Model with a trainer, while the control group receives standard training at their institution

8 weeks

Assessment

Participants' Vaginal Surgical Skills Index (VSSI) scores are assessed to compare the effectiveness of the training

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

Treatment Details

Interventions

  • Miyamodel Training
Trial Overview The study is testing whether practicing with a simulation tool called the Miya Model can improve the performance of novice surgeons during actual vaginal hysterectomy operations in the operating room.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
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 II: Control groupActive Control1 Intervention
The training will be whatever is standard at their Institution

Miyamodel Training is already approved in United States for the following indications:

🇺🇸
Approved in United States as Miya Model for:
  • Training for Vaginal Hysterectomy (VH)
  • Basic Gynecological Examination
  • Pelvic Surgery Techniques

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Findings from Research

The Miya Model™ was found to be an effective simulation tool for training and assessing vaginal hysterectomy skills, with 80% of novice and 100% of expert participants rating it positively.
The model demonstrated high interrater reliability for evaluating surgical performance, indicating it could be a reliable assessment tool for both novice and expert gynecologists.
Validation of an educational simulation model for vaginal hysterectomy training: a pilot study.Miyazaki, D., Matthews, CA., Kia, MV., et al.[2020]
The simulated vaginal hysterectomy trainer (SimVaHT) was validated as an effective tool for teaching surgical skills, showing that senior residents scored significantly higher than junior residents on the Global Rating Scale (GRS), indicating improved skill levels.
The study involved 14 obstetrics and gynecology residents and demonstrated that the SimVaHT is a practical and cost-effective method to enhance surgical training before actual operations.
Validation of the Simulated Vaginal Hysterectomy Trainer.Vaughan, MH., Kim-Fine, S., Hullfish, KL., et al.[2019]
The modified Flowerpot Model for transvaginal hysterectomy (TVH) demonstrated strong face and construct validity, as evidenced by high satisfaction rates (92% satisfaction with simulation realism) among 14 surgical residents and fellows.
Junior residents showed significant improvement in comfort and confidence after using the model, while senior residents had higher overall confidence scores, indicating the model effectively enhances training for less experienced surgeons.
Validation of Transvaginal Hysterectomy Surgical Model - Modification of the Flowerpot Model to Improve Vesicovaginal Plane Simulation.Burkett, LS., Makin, J., Ackenbom, M., et al.[2022]

References

Validation of an educational simulation model for vaginal hysterectomy training: a pilot study. [2020]
Validation of the Simulated Vaginal Hysterectomy Trainer. [2019]
Validation of Transvaginal Hysterectomy Surgical Model - Modification of the Flowerpot Model to Improve Vesicovaginal Plane Simulation. [2022]
The impact of a simulation-based training lab on outcomes of hysterectomy. [2020]
Development and validation of simulation training for vaginal hysterectomy. [2019]
Vaginal Hysterectomy Suturing Skills Training Model and Curriculum. [2021]
Surgical Simulation and Competency. [2017]
Multiparous Ewe as a Model for Teaching Vaginal Hysterectomy Techniques. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security