Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
2019年1月23日 更新者:Jon I. Einarsson、Brigham and Women's Hospital
A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
70
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Boston、Massachusetts、美国、02115
- Brigham & Women's Hospital
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Boston、Massachusetts、美国、02130
- Faulkner Hospital
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
70 adult women scheduled to undergo a laparoscopic hysterectomy
描述
Inclusion Criteria:
- 18 years of age or greater
- eligible to undergo laparoscopic Hysterectomy, as determined clinically by the operating surgeon
Exclusion Criteria:
- suspected malignancy
- medical illness precluding laparoscopy
- inability to give informed consent
- allergy to indigo carmine or methylene blue dye
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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minilaparotomy
Subjects in this group will have tissue (uterus) extracted via mini-laparotomy incision with knife morcellation.
Morcellation will be performed within a containment system.
Method of extraction/group assignment will be determined clinically by the operating surgeon based on patient characteristics and patient preference.
|
vaginal extraction
Subjects in this group will have tissue (uterus) extracted via vaginal extraction with knife morcellation.
Morcellation will be performed within a containment system.
Method of extraction/group assignment will be determined clinically by the operating surgeon based on patient characteristics and patient preference.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Return to daily activities
大体时间:assessed between 2 and 6 weeks after surgery (at post-op visit)
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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).
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assessed between 2 and 6 weeks after surgery (at post-op visit)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
OR Time
大体时间:At the time of surgery
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minutes from procedure start to procedure end
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At the time of surgery
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Estimated Blood Loss
大体时间:At the time of surgery
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ml of blood loss based on surgeon estimate
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At the time of surgery
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Spillage of the morcellated tissue or fluids in the abdomen and pelvis
大体时间:At the time of surgery
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Following morcellation and removal of the bag, the abdomen and pelvis will be carefully examined for any signs of spillage of fluid, tissue or blue dye as well as the integrity of the containment system by the surgeon
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At the time of surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jon I Einarsson, MD, PhD, MPH、Brigham and Women's Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年4月1日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2015年7月9日
首先提交符合 QC 标准的
2015年7月9日
首次发布 (估计)
2015年7月14日
研究记录更新
最后更新发布 (实际的)
2019年1月25日
上次提交的符合 QC 标准的更新
2019年1月23日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.