Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Spillage of intracystic content rate
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •reproductive age
- •pre-operative findings suggestive for benign tumor
- •regular menstrual cycles at least six months before surgery
排除标准
- •previous pelvic surgery
- •known endocrine disease
- •estrogen-progestin use before surgery
结局指标
主要结局
Spillage of intracystic content rate
时间窗: Intraoperative
Operative times
时间窗: Immediately at the end of the laparoscopy
Operative times will be assessed when surgeons will end the laparoscopy, specifically when he will end the suture of the last skin scar.
Chemical peritonitis rate
时间窗: 1 week after surgery
Intraoperative blood loss
时间窗: The morning after laparoscopy
The first patient blood sample will be taken the morning of the surgery, at h 8 am. The day after, it will be taken the second blood sample. Intraoperative blood loss wil be calculated by deducting Hb values of the second hemocrome by the first one.
次要结局
- Ovarian reserve(3 months and 1 year after surgery)
研究者
Fulvio Zullo
Full Professor
University Magna Graecia