A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Trocar Slippages With LaproStop
研究概览
简要总结
The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage.
Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.
排除标准
- 未提供
研究组 & 干预措施
Ethicon Xcel Trocars
Ethicon Xcel trocars will be used in this arm with Laprostop device
干预措施: LaproStop (Device)
Covidien Veraport Trocars
Covidien Veraport Trocars will be used in this arm with the Laprostop device
干预措施: LaproStop (Device)
Storz Reusable Trocars
Storz Reusable Trocars will be used in this arm with the Laprostop device
干预措施: LaproStop (Device)
结局指标
主要结局
Trocar Slippages With LaproStop
时间窗: During the hysterectomy procedure, up to 2 hours and 32 minutes
Number of participants with slippages with LaproStop
次要结局
- Trocar Slippages Without LaproStop(During the hysterectomy procedure, up to 2 hours and 32 minutes)
研究者
Jon I. Einarsson
MD, MPH
Brigham and Women's Hospital