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临床试验/NCT02496130
NCT02496130已完成不适用

A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

Brigham and Women's Hospital3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年4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
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon I. Einarsson

Chief, Division of Minimally Invasive Gynecology

Brigham and Women's Hospital

研究点 (3)

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