Comparing Surgical Proficiency of Laparoscopic Vaginal Cuff Suturing in Surgically Naïve Learners After Training With Two Different Laparoscopic Simulators: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators
研究概览
简要总结
Surgically naive premedical and medical students were trained on two different laparoscopic simulation trainers, then tested on the same vaginal cuff suturing model. Video recordings were collected from the vaginal cuff suturing tasks. These recordings were graded by expert gynecologic surgeons using a laparoscopic skills rubric. Their scores were compared to determine if one of the two laparoscopic trainers better prepared surgically naive students to complete a gynecologic surgical task.
详细描述
Surgically naive premedical and medical students were recruited from June-November 2019. They were block randomized into two laparoscopic simulation training groups: Essentials in Minimally Invasive Gynecology (EMIG) or Fundamentals of Laparoscopic Surgery (FLS). Demographic data was collected from all participants. Participants watched instructional videos specific to their simulation trainer, as well as a video for the vaginal cuff suturing task. Participants then completed a pre-test on a vaginal cuff laparoscopic suturing model. They underwent EMIG or FLS training for approximately 2.5 hours. After training, they completed a post-test on the same vaginal cuff laparoscopic suturing model. Both pre- and post-test tasks were recorded. Video recordings were reviewed and graded by two expert high-volume MIGS surgeons who were masked to participant group (EMIG or FLS) and test phase (pre- or post-test). A modified version of the previously validated GOALS tool was used for grading. Participants also completed a survey rating their confidence level in performing laparoscopic tasks using a 5-point Likert scale after completion of their post-test vaginal cuff suturing task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current student enrolled in premedical internship program at Northwestern during recruitment dates
- •current medical student in M1/M2 preclinical years enrolled in accredited medical school
- •MD/PhD student in their PhD year(s) enrolled in accredited medical school
排除标准
- •medical student in M3/M4 clinical years enrolled in accredited medical school
结局指标
主要结局
Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators
时间窗: 4 hours
Using a previously validated laparoscopic skills assessment tool (Global Operative Assessment of Laparoscopic Skills, or GOALS), two expert MIGS surgeons reviewed each video and scored it using a modified version of the GOALS tool. Each participant was ultimately given a GOALS composite score, which was made up of 8 individual skill domains (3 of which were added to make the scoring relevant and specific to the vaginal cuff suturing task). The GOALS scores serve to measure student surgical proficiency at laparoscopic tasks.
次要结局
- Correlation of fine motor skills task experience with laparoscopic surgical task performance(4 hours)
研究者
Magdy Milad, MD
Albert B. Gerbie Professor; Chief, Gynecology and Gynecologic Surgery
Northwestern University