Breast Cancer Clinical Trial
— AMASTECOfficial title:
Feasibility of Total Mastectomy in Ambulatory Care
Verified date | September 2023 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 1 |
Est. completion date | September 12, 2023 |
Est. primary completion date | September 12, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patient with an indication of breast non conserving surgery Exclusion Criteria: - Standard contra-indication for ambulatory care. - Also bilateral surgery and immediate breast reconstruction. |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens | Centre Hospitalier de Beauvais, Centre Hospitalier de Saint-Quentin |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of ambulatory care after total mastectomy allowed with PADSS score | 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. | day 0= day of surgery |
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