Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- second diagnostic hysteroscopy
研究概览
简要总结
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.
详细描述
The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 20-40 years;
- •Moderate to severe intrauterine adhesion (AFS score ≥5）;
- •complains of menstruation disorder and reproductive dysfunction
- •Agreement to have second-look hysteroscopy
- •informed consent
排除标准
- •ovarian failure
- •patients who did not proceed to second-look hysteroscopy within the specified time frame
- •Contraindication of hormone
研究组 & 干预措施
Foley catheter
After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.
干预措施: Foley catheter (Device)
Disposable balloon uterine stent
After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery.
干预措施: disposable balloon uterine stent (Device)
结局指标
主要结局
second diagnostic hysteroscopy
时间窗: Within the first 3 months after surgery
AFS score（The American Fertility Society classifications）
次要结局
- Menstruation Pattern(Within the first 3 months after surgery)
- Number of participants with pregnancy(one year)