Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Egg Albumin Leakage.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation.
The hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.
详细描述
Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.
In order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. Due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag.
This study will be evaluating the efficacy of contained morcellation using a specific specimen bag. Morcellation will be performed in the designated bag. The bag will then be removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •adult premenopausal women (equal or greater than 18 years old)
- •no symptoms of menopause
- •undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids
- •not candidates for specimen removal via mini-laparotomy incision (as deemed by the study surgeon) or who have refused mini-laparotomy
- •endometrial biopsy with no suspicion for malignancy
排除标准
- •known or suspected malignancy
- •peri- or post-menopausal women
- •specimen that can be removed without power morcellation (e.g., vaginally or through laparoscopic trocars)
- •adults unable to consent.
研究组 & 干预措施
EcoSac 46 400 ECO-T morcellation bag cohort
Prospective study of one cohort of subjects undergoing power morcellation within the EcoSac 46 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.
干预措施: EcoSac 400 ECO-T (Device)
结局指标
主要结局
Number of Participants With Egg Albumin Leakage.
时间窗: Day 0 through the end of morcellation, approximately 30 minutes.
After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."
次要结局
- Morcellation Time(Day 0 through the end of morcellation, approximately 30 minutes.)