Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Length of displacement when in Trendelenburg
研究概览
简要总结
To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.
详细描述
Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
- •Patients must not be pregnant
排除标准
- •Pregnancy
- •Patients unable to give consent
结局指标
主要结局
Length of displacement when in Trendelenburg
时间窗: 1 day
Normal amount of displacement when place in Trendelenburg
次要结局
- Cost of device(1 day)
- Patient BMI(1 day)
- Rank of ease of use by physician(1 day)
- Number of adverse events(1 day)
- Erythema score(1 day)
- Patient age(1 day)
- Patient weight(1 day)
- Patient height(1 day)
- Patient Hip circumference(1 day)
- Patient Waist circumference(1 day)