The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The number of complications after adhesiolysis
研究概览
简要总结
Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation.
A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.
We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to study its feasibility in terms of surgeon's and patient's experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
排除标准
- 未提供
结局指标
主要结局
The number of complications after adhesiolysis
时间窗: 5-10 weeks after adhesiolysis
The number of recurrent adhesions after adhesiolysis
时间窗: 5-10 weeks after adhesiolysis
次要结局
- Pain at the time of the removal of the intra uterine balloon(6 days after adhesiolysis)
- Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)(6 days after adhesiolysis)
- Pain after placement of the intra uterine balloon(1 to 6 days after adhesiolysis)
- Patient Satisfaction after removal of the intra uterine balloon(6 days after adhesiolysis)
- Complications after placement of the intra uterine balloon(1 to 6 days after adhesiolysis)
- Malaise after placement of the intra uterine balloon(6 days after adhesiolysis)
- The ease of inserting the intra uterine balloon(once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study)
- The ease of removing the intra uterine balloon(6 days after adhesiolysis)