Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adhesion formation postoperatief.
研究概览
简要总结
Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.
Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.
详细描述
Design:
Double-blind, randomized controlled pilot trial.
Participant:
- age between 18 and 45 years.
- intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
- absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
Treatment:
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
None of the participants will be informed of the allocated treatment by the surgeon or the personnel present in the OR. The medical record will not reveal any information whether antiadhesion gel was applied at the end of the procedure. In the case that the surgeon is the same person as the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 45 years.
- •intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
- •absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
排除标准
- •pregnancy.
- •laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
- •presence of endometritis.
- •other antiadhesion methods
研究组 & 干预措施
intrauterine gel application
Application of Hyalobarrier intrauterine after myomectomy.
干预措施: Hyalobarrier (Device)
no intra-uterine gel application
No application of Halobarrier intrauterine after myomectomy.
结局指标
主要结局
Adhesion formation postoperatief.
时间窗: 3 months post surgery
The presence of intra-uterine adhesions on a second look hysteroscopy.
次要结局
- Severity of adhesion formation(3 months post surgery, at the time of the hysteroscopy.)