NCT03281564已完成不适用
Prospective Study of Quality of Life After Laparoscopic Removal of Essure®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Quality of life 1 month after laparoscopic removal of Essure®
研究概览
简要总结
A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18 years or more
- •patients with Essure® sterilization device
- •surgical removal of Essure® with bilateral salpingectomy by laparoscopy
排除标准
- •interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- •impaired lower-limb range of motion preventing positioning for surgery
- •inability to understand information provided
- •prisoner or under administrative supervision.
结局指标
主要结局
Quality of life 1 month after laparoscopic removal of Essure®
时间窗: 1 month
Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device
次要结局
未报告次要终点
研究者
研究点 (1)
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