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?

This trial aims to determine if the Miya Model, a simulation training system, can improve new surgeons' performance during vaginal hysterectomies, a procedure to remove the uterus through the vagina. The trial includes two groups: one receives the usual training, while the other practices on the Miya Model with expert feedback. The trial seeks medical residents who have performed ten or fewer vaginal hysterectomies and lack specialized training in this area. As an unphased study, it offers residents a unique opportunity to enhance their surgical skills through innovative training methods.

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 prior data suggests that the Miya Model Simulator is safe for training novice surgeons?

Research has shown that the Miya Model is highly regarded for training in vaginal hysterectomy, a surgery to remove the uterus through the vagina. In one study, 80% of beginners and all experts found it effective or very effective for training. This model mimics real surgical experiences, allowing surgeons to practice important skills in a realistic and stress-free environment.

As a simulation tool, not a drug or device used on patients, there are no reports of negative effects. The Miya Model enhances learning and skill development, ensuring safety for training purposes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MiyaModel Training for vaginal hysterectomy skills because it offers a hands-on, realistic simulation experience. Unlike traditional training methods, which may rely heavily on observation or limited practice, this approach allows residents to perform multiple hysterectomy procedures on a lifelike model. This method ensures that trainees receive immediate feedback and are evaluated by experts, helping them refine their skills to reach a high proficiency level. By enhancing surgical confidence and competence through repeated practice, the MiyaModel Training could lead to improved surgical outcomes and patient safety.

What evidence suggests that the Miya Model Simulator is effective for improving vaginal hysterectomy skills?

Research has shown that the Miya Model effectively teaches vaginal hysterectomy skills. In one study, 80% of beginners and all experts found it effective or very effective. Another study demonstrated that it helped new surgeons perform better in the operating room. The Miya Model also boosts confidence and knowledge in performing these surgeries. In this trial, participants in the intervention group will receive standardized training using the Miya Model. Overall, evidence strongly supports the Miya Model as a valuable tool for learning vaginal hysterectomy techniques. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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]

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-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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30191250/

Validation of an educational simulation model for vaginal ... Most participants (80% of novice and 100% of expert group) rated the model as effective or highly effective for vaginal hysterectomy training and assessment.

2. trialx.com trialx.com/clinical-trials/listings/248307/effect-of-validated-skills-simulation-with-the-miya-model/

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 ...

3. withpower.com withpower.com/trial/simulation-training-for-vaginal-hysterectomy-skills-97b8e

Simulation Training for Vaginal Hysterectomy Skills 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 ...

4. nichd.nih.gov nichd.nih.gov/grants-contracts/SBIR_STTR/showcase/Miya-Model

Miya Model™ – Surgical Training Simulator for Obstetrician ... The Miya Model™ simulates real surgical experiences to provide better training for residents in vaginal surgical techniques. The simulator ...

5. jscimedcentral.com jscimedcentral.com/jounal-article-info/Medical-Journal-of-Obstetrics-and-Gynecology/Effectiveness-of-Simulation-Training-for-Vaginal-Hysterectomy-(Using-a-Commercially-Available-High-Fidelity-Model)-12215

Effectiveness of Simulation Training for Vaginal ... Conclusions: A commercially available VH model increased residents' confidence and knowledge scores in performing VH. This VH model can serve as ...

6. blogs.the-hospitalist.org blogs.the-hospitalist.org/content/how-teach-vaginal-surgery-through-simulation

How to teach vaginal surgery through simulation | MDedge The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication ...

7. healthcarebusinessreview.com healthcarebusinessreview.com/miyazaki-enterprises

Miyazaki Enterprises Miya Model™ Leads the Way in ... This model offers a realistic simulation of the female pelvic anatomy, allowing residents to refine their skills in a stress-free environment.