A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Ovarian function preservation 12 weeks after surgery
研究概览
简要总结
This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.
详细描述
In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.
Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.
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
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent.
- •Age: 19-45 year-old women
- •American Society of Anesthesiologists Physical Status classification 1 or 2
- •Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
- •Regular menstruation every 21-45 days
排除标准
- •No 'ovarian' endometriosis
- •Suspicious disease of ovarian malignancy
- •Age: 18 and younger, 46 and older
- •Pregnancy or breastfeeding.
- •Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
- •Hormonal therapy within recent 3 months
- •Considered as inappropriate by the researcher's judgment.
结局指标
主要结局
Ovarian function preservation 12 weeks after surgery
时间窗: 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
次要结局
- Transfusion during admission(post-op 2 days)
- the success rate of hemostasis within 10 minutes(during operation)
- Ovarian function preservation 48 weeks after surgery(48 weeks after surgery)
- Blood loss during operation(during operation)
- Hemoglobin(post-op 2 days, 12 weeks and 48 weeks)
- Adverse events associated with operation, bleeding or transfusion(post-op 2 days)
- Hospitalization period(within post-op 2 weeks)
- The time required to finish hemostasis(during operation)
- Operation running time(during operation)
研究者
Hee Seung Kim
associate professor
Seoul National University Hospital