Simulation Training for Vaginal Hysterectomy Skills

Overseen By Douglas Miyazaki

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Prior VH training, Performed 11+ VHs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Who Is on the Research Team?

Leslie Kammire, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 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 group Active Control 1 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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Simulation-based training significantly reduced average estimated blood loss during total abdominal hysterectomy (TAH) and robot-assisted hysterectomy (RAH), indicating improved surgical performance after training.

Residents who underwent simulation training also experienced shorter hospital stays across all hysterectomy techniques, suggesting enhanced surgical outcomes and efficiency in patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a simulation-based training lab on outcomes of hysterectomy. Asoğlu, MR., Achjian, T., Akbilgiç, O., et al.[2020]

A simulation-based educational intervention for vaginal hysterectomy significantly improved written test scores for all 30 Obstetrics and Gynecology residents, indicating enhanced knowledge after the training.

Junior residents (PGY-2) showed a notable increase in self-rated confidence in performing vaginal hysterectomy, highlighting the intervention's effectiveness in boosting confidence among those with limited prior exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of simulation training for vaginal hysterectomy. Greer, JA., Segal, S., Salva, CR., et al.[2019]

A low-fidelity simulation curriculum for vaginal hysterectomy was developed, allowing residents to practice essential suturing tasks, with 30 residents participating in the study.

The curriculum showed promise, as 92% of residents believed it would enhance their surgical skills, and the pass rates improved significantly for more complex tasks, indicating its potential as an effective training tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal Hysterectomy Suturing Skills Training Model and Curriculum. Balgobin, S., Owens, DM., Florian-Rodriguez, ME., et al.[2021]

Simulation is becoming essential in surgical training, especially in obstetrics and gynecology, due to rising education costs and a focus on patient safety.

The article proposes a structured framework for teaching hysterectomy through simulation, emphasizing the need for standardized curricula to enhance competency in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Simulation and Competency. Kim-Fine, S., Brennand, EA.[2017]

Vaginal hysterectomy is declining in use due to a lack of practical training, and this study proposes using ewes as a training model to improve surgical education.

The study demonstrated that the surgical steps of vaginal hysterectomy performed on ewes closely resemble those performed on humans, suggesting that this model could effectively enhance training for medical professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparous Ewe as a Model for Teaching Vaginal Hysterectomy Techniques. Kerbage, Y., Cosson, M., Hubert, T., et al.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Validation of an educational simulation model for vaginal hysterectomy training: a pilot study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Validation of the Simulated Vaginal Hysterectomy Trainer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Validation of Transvaginal Hysterectomy Surgical Model - Modification of the Flowerpot Model to Improve Vesicovaginal Plane Simulation. [2022]

4. Turkey pubmed.ncbi.nlm.nih.gov

The impact of a simulation-based training lab on outcomes of hysterectomy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Development and validation of simulation training for vaginal hysterectomy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Vaginal Hysterectomy Suturing Skills Training Model and Curriculum. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical Simulation and Competency. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Multiparous Ewe as a Model for Teaching Vaginal Hysterectomy Techniques. [2018]