Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 10
- 主要终点
- Patient satisfaction following gel application
研究概览
简要总结
Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.
详细描述
Operations in the uterus are currently possible using a hysteroscopic approach. Intrauterine procedures include; polypectomy, myomectomy, removal of lost IUD,removal of a septum and more. One serious though rare complication of operative hysteroscopy is the development of intra-uterine adhesions. Such adhesions, also known as asherman's syndrome, can cause serious consequences such as infertility and miscarriage. The hypothesis is that the removal of the endometrium and the exposure of ra uterine wall to each other can cause attachment and adhesions. the treatment is to mechanically break the adhesion. recurrence is however common. There currently are no methods to prevent adhesions following curettage or hysteroscopy. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery. At a later research, the efficacy of barrier gel will be measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18 year old and over
- •need of hysteroscopic surgery
排除标准
- •preoperative fever or infection
- •malignancy
- •previous PID
- •contraindications for anesthesia
- •pregnancy
- •under 18 year old
- •not able to read and/or understand informed consent
- •taking any medicine other than oral contraceptives
研究组 & 干预措施
Hyaluronan
Use of hyaluronic acid gel
干预措施: Hyaluronan (Drug)
结局指标
主要结局
Patient satisfaction following gel application
时间窗: 2 months
次要结局
未报告次要终点
