Clinical Trials Directory

Trials / Completed

CompletedNCT05418764

Effect of Validated Skills Simulation With the Miya Model

Effect of Validated Skills Simulation With the Miya Model on Operating Room Performance of Vaginal Hysterectomy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

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

Timeline

Start date
2021-12-27
Primary completion
2025-10-13
Completion
2025-10-13
First posted
2022-06-14
Last updated
2026-04-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05418764. Inclusion in this directory is not an endorsement.