Randomized, Controlled Trial Comparing Immediate and Delayed Intrauterine Balloon Therapy 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
- 180
- 试验地点
- 1
- 主要终点
- AFS score
研究概览
简要总结
In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
详细描述
Objectives
To compare the efficacy of placing an Intrauterine Balloon immediately after surgery and delayed Intrauterine Balloon Dilatation Therapy after surgery in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
Patients
The patients will be recruited from two centers, namely, the HysterscopyCenter of the Fuxing Hospital and TianTan Hospital, Capital Medical University, Beijing, China.Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations, including a detailed history of the menstrual pattern, any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography.The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). The inclusion criteria include [1] women aged 18-40 years; [2] moderate to severe intrauterine adhesion (AFS score≥5); [3] first episode of hysteroscopic adhesiolysis in the investigators hospital; [4] written consent obtained; and [5] agreement to have second-look hysteroscopy. The exclusion criteria include [1] minimal adhesion (AFS score <5) and [2] previous hysteroscopic adhesiolysis in the investigators hospital.
Study Design
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-40 years;
- •moderate to severe intrauterine adhesion (AFS score≥5);
- •first episode of hysteroscopicadhesiolysis in our hospital;
- •written consent obtained;
- •agreement to have second-look hysteroscopy.
排除标准
- •minimal adhesion (AFS score <5)
- •previous hysteroscopic adhesiolysis in our hospital.
结局指标
主要结局
AFS score
时间窗: at 6 weeks post-op
The degree of intrauterine adhesions described by AFS score reduction at second look hysteroscopy
次要结局
- infection rate(at 6 weeks post-op)
- The menstrual pattern(at 6 weeks post-op)
研究者
Xiaoyu Shi
Principal Investigator
Fu Xing Hospital, Capital Medical University