A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Return to daily activities
研究概览
简要总结
The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.
详细描述
The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery, including vaginal extraction and mini-laparotomy; both performed within a containment system. The primary aim is to assess return to normal daily activities after each of the surgical techniques. Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable). Additional information regarding post-operative pain (measured on a Likert scale), potential complications of each technique, such as tearing of the bag or leakage, and peri- and post-operative outcomes will be collected. In order to aid in detection of leakage, blue dye (either indigo carmine or methylene blue) will be added to the containment bag prior to morcellation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or greater
- •eligible to undergo laparoscopic Hysterectomy, as determined clinically by the operating surgeon
排除标准
- •suspected malignancy
- •medical illness precluding laparoscopy
- •inability to give informed consent
- •allergy to indigo carmine or methylene blue dye
结局指标
主要结局
Return to daily activities
时间窗: assessed between 2 and 6 weeks after surgery (at post-op visit)
Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable).
次要结局
- OR Time(At the time of surgery)
- Estimated Blood Loss(At the time of surgery)
- Spillage of the morcellated tissue or fluids in the abdomen and pelvis(At the time of surgery)
研究者
Jon I. Einarsson
Chief, Division of Minimally Invasive Gynecology
Brigham and Women's Hospital
