Clinical trial NCT03604666: Follow-up of Elderly Patients in Ambulatory Surgery
Official title: Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Skin Cancer
Surgery
Ambulatory
Keywords: Breast Cancer
Skin cancer
Surgery
Ambulatory
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 320
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 75 years consulting at the dermatological crossroads or "crossroads breast" and requiring surgery for a cancer of the skin or breast (without reconstruction)

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients operated on an outpatient basis
timeFrame: 3 month
Secondary outcomes:
measure: Number of death
timeFrame: at Day 30 and Day 90
measure: Number of patients converted to conventional care
timeFrame: at Day 30 and Day 90
measure: Number of the passage to emergencies
timeFrame: at Day 30 and Day 90
measure: Number of not programmed hospitalizations
timeFrame: at Day 30 and Day 90
measure: The autonomy Activities of Daily Living (ADL)
timeFrame: at Day 30 and Day 90
measure: The autonomy Instrumental Activities of Daily Living (IADL)
timeFrame: at Day 30 and Day 90
measure: Number of institutionalization to Long-term care and skilled nursing facilities
timeFrame: at Day 30 and Day 90
measure: Number of passage to Long-term care and skilled nursing facilities
timeFrame: at Day 30 and Day 90
measure: Number of postoperative complications
timeFrame: at Day 90
measure: Costs of care
timeFrame: at Day 30 and Day 90
measure: Patients' satisfaction (questionnaire) for the prospective part of the study
timeFrame: at Day 30 and Day 90
measure: Patient's quality of life (EQ50 questionnaire, for the prospective part of the study)
timeFrame: at Day 30 and Day 90
Other outcomes:
Locations:
city: Créteil
country: France
facility: Bosc
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Romain BOSC, MD
role: PRINCIPAL_INVESTIGATOR
References: