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临床试验/NCT04270136
NCT04270136已完成不适用

Feasibility of Total Mastectomy in Ambulatory Care

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
2
主要终点
number of ambulatory care after total mastectomy allowed with PADSS score

研究概览

简要总结

Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All patient with an indication of breast non conserving surgery

排除标准

  • Standard contra-indication for ambulatory care.
  • Also bilateral surgery and immediate breast reconstruction.

结局指标

主要结局

number of ambulatory care after total mastectomy allowed with PADSS score

时间窗: day 0= day of surgery

Post Anaesthetic Discharge Scoring System (PADSS), which considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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