Effect of Validated Skills Simulation With the Miya Model on Operating Room Performance of Vaginal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Vaginal Surgical Skills Index (VSSI) scores - Intervention Group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will perform 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 - o Residents in the simulation arm will train until they reach a score of 27 on the modified Vagina Surgical Skills Index (VSSI)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •residents at participating Institutions
- •residents have performed ten or fewer vaginal hysterectomies
排除标准
- •having had prior training dedicated to vaginal hysterectomy
- •having performed eleven or more vaginal hysterectomies in the OR
研究组 & 干预措施
Intervention group
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)
干预措施: Miyamodel Training (Other)
Control group
The training will be whatever is standard at their Institution
结局指标
主要结局
Vaginal Surgical Skills Index (VSSI) scores - Intervention Group
时间窗: Month 2
compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance
Vaginal Surgical Skills Index (VSSI) scores - Control Group
时间窗: Month 2
compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance
次要结局
未报告次要终点