Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Improving the quality of life between pre and post-operative at 3 months
研究概览
简要总结
To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.
详细描述
Tubal sterilization is a widely used method of contraception. The hysteroscopic sterilization method (Essure®; Bayer, Germany) was approved in 2007 in France. Increasing patients reports of complications, such as bleeding pain, allergies, fatigue or articular pain have raised concerns about the safety device. Women suffering of alleged complications of the Essure® device ask for surgical removal. But, only few studies have assessed Essure® removal in terms of quality of life. This observational study contains two parts will be conducted at two academic tertiary care center (Montpellier - Marseille):
- a prospective part having received a favorable opinion from a Committee for the Protection of Persons,
- and a retrospective part having received a favorable opinion from the Institutional Review Board (IRB), local ethics committee
Patients: Women requesting surgical management for removal of Essure® for alleged adverse effects.
Assessment tools :
Quality of life with the Short Form 36 (SF-36) Health Survey questionnaire (pre-operatively and at 1 and 3 months) Hospital Anxiety and Depression (HAD) scale (pre-operatively and 3 months)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients carrying Essure®
- •Patients requesting surgical removal of Essure®
- •Patients with adverse effect
- •Being affiliated or benefiting from a French social security system
排除标准
- •Patients with guardianship or curators
结局指标
主要结局
Improving the quality of life between pre and post-operative at 3 months
时间窗: 3 months after the surgery
The quality of life is measure with Short Form (36) Health Survey Questionnaire
次要结局
- General disorders and anxiety or depression(One month before surgery and 3 months after surgery.)
- Allergy to components(During surgical removal)
- Defects in installation or secondary migration(during surgery)
- Performance of 3D ultrasound(Preoperatively)