NCT03003169已完成不适用
Mastectomy in Ambulatory Breast Surgery
Institut de Cancérologie de Lorraine1 个研究点 分布在 1 个国家目标入组 419 人开始时间: 2016年4月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.
研究概览
简要总结
This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.
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
- •patient managed for breast cancer surgery
- •age >18 years old
- •understand and comply with the requirements of the study
- •patient must be affiliated to a social security system
排除标准
- •patient managed for a concomitant reconstructive surgery
- •bilateral breast surgery
- •patient already included in another clinical trial with an experimental molecule
- •patient deprived of liberty or under supervision
- •neoadjuvant therapy
结局指标
主要结局
Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.
时间窗: 15 days
Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23
次要结局
- Estimate the conversion rate from ambulatory surgical to conventional surgery(15 jours)
- Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)(15 jours)
- Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery.(15 days)
- Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)(15 days)
研究者
研究点 (1)
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