跳至主要内容
临床试验/NCT01969487
NCT01969487已完成不适用

Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
4
主要终点
Surgical skill metrics

研究概览

简要总结

Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room. Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Care Provider, 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

入选标准

  • Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution;
  • Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer.

排除标准

  • Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.

结局指标

主要结局

Surgical skill metrics

时间窗: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)

Computed using surgical tool motion and/or video of procedure.

Global rating score - GEARS approach

时间窗: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)

Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills (OSATS) and the Global Evaluative Assessment of Robotic Surgery (GEARS).

Global rating score - OSATS approach

时间窗: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)

Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills and the Global Evaluative Assessment of Robotic Surgery.

次要结局

  • Length of hospital stay(We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.)
  • Estimated blood loss(Intraoperative)
  • Change in hematocrit(Postoperative days 1, 2, and 3)
  • Operative time(Intraoperative)
  • Readmission or emergency room visit(6 weeks after discharge from hospital (following initial admission for surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验