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临床试验/NCT03604666
NCT03604666Unknown不适用

Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
320
试验地点
1
主要终点
Number of patients operated on an outpatient basis

研究概览

简要总结

The number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. But the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment.

The goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital on the increase in the proportion of patients operated on an outpatient basis

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ≥ 75 years old with breast cancer or skin cancer and requiring surgical excision: partial mastectomy, lumpectomy, axillary dissection, cutaneous excision, etc.
  • With an indication of ambulatory care
  • Patient (legal representative or trusted person or member of the family) having been informed and having given his non-oral objection to his participation in the study
  • Possessing a health insurance

排除标准

  • Patients reserved for breast reconstruction to the operative gesture of tumor resection.
  • Patients do not consent to care because of deficient mental state.
  • Formal surgical contraindication due to a pathology medical device does not allow anesthesia. - Participation in another interventional research or be in the exclusion period after a previous search, if applicable

结局指标

主要结局

Number of patients operated on an outpatient basis

时间窗: 3 month

Test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital

次要结局

  • Number of the passage to emergencies(at Day 30 and Day 90)
  • Number of patients converted to conventional care(at Day 30 and Day 90)
  • Costs of care(at Day 30 and Day 90)
  • Patient's quality of life (EQ50 questionnaire, for the prospective part of the study)(at Day 30 and Day 90)
  • Number of postoperative complications(at Day 90)
  • Number of death(at Day 30 and Day 90)
  • The autonomy Instrumental Activities of Daily Living (IADL)(at Day 30 and Day 90)
  • The autonomy Activities of Daily Living (ADL)(at Day 30 and Day 90)
  • Number of not programmed hospitalizations(at Day 30 and Day 90)
  • Number of institutionalization to Long-term care and skilled nursing facilities(at Day 30 and Day 90)
  • Patients' satisfaction (questionnaire) for the prospective part of the study(at Day 30 and Day 90)
  • Number of passage to Long-term care and skilled nursing facilities(at Day 30 and Day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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