Efficacy of In-bag Morcellation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Smooth muscular cells in the peritoneal fluid after morcellation
研究概览
简要总结
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.
The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Women aged 18 years or more
- •Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
- •Informed and signed consent
排除标准
- •Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- •Preoperative risk of leiomyosarcoma or pelvic carcinoma
- •Pregnancy or desire of pregnancy during the study period
- •Uterus or myomas weight above 1.000 g
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision
研究组 & 干预措施
with in-bag morcellation
with More-cell-Safe AMI bag morcellation
干预措施: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation (Device)
without any morcellation bag
without any morcellation bag
干预措施: laparoscopic myomectomy or hysterectomy without any morcellation bag (Procedure)
结局指标
主要结局
Smooth muscular cells in the peritoneal fluid after morcellation
时间窗: Day 0 - just after surgery
After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum
次要结局
- bag associated time(Day 0 - during surgery)
- duration of surgery(Day 0)
- morcellation time(Day 0 - during surgery)
- peritoneal washing time(Day 0 - during surgery)
- residual morcellated tissues weight(Day 0 - during surgery)
- ease of use(Day 0 - during surgery)