A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Hemostasis
研究概览
简要总结
The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy
详细描述
In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 years ≤ Ages <45 years
- •laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography
- •women with regular menstruation
- •women with regular menstruation cycle from 21 days to 45 days
- •Proper state for laparoscopic operation (American society of Anesthesiologists Physical Status classification 1 or 2)
- •Patients who signed and approved informed consent
排除标准
- •Patients without ovarian cyst
- •Patients with malignant female genital disease
- •Patients with bilateral ovarian cysts
- •Pregnancy or lactating women
- •Serum AMH<0.05 ng/ml
- •Patients with endocrine disease such as thyroid abnormality, hyperprolactinemia, cushing disease, etc
- •Patients with hormone replacement therapy during 3 months
- •Patients who is considered to be difficult to perform the clinical trial when researchers judge
研究组 & 干预措施
SurgiGuard
Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery
干预措施: Surgiguard (Drug)
结局指标
主要结局
Hemostasis
时间窗: post operative 48 hours later,1 week later, and 12 weeks later
Change of serum hemoglobin from baseline
次要结局
- Ovarian function preservation(post operative 48 hours later,1 week later, and 12 weeks later)
- Volume of ovary(post operative 48 hours later,1 week later, and 12 weeks later)
研究者
Hee Seung Kim
Associate Professor, Department of Obstetrics & Gynecology
Seoul National University Hospital