Effect of Validated Skills Simulation With the Miya Model

Wake Forest University (WFU)

Status: Enrolling

Conditions: Vaginal Hysterectomy

Treatments: Other: Miyamodel Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05418764

IRB00072056

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Intervention group

Experimental group

Description:

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)

Treatment:

Other: Miyamodel Training

Control group

No Intervention group

Description:

The training will be whatever is standard at their Institution