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Feasibility of Total Mastectomy in Ambulatory Care

Feasibility of Total Mastectomy in Ambulatory Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04270136
Acronym
AMASTEC
Enrollment
1
Registered
2020-02-17
Start date
2021-01-01
Completion date
2023-09-12
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Mastectomy, Ambulatory Care

Keywords

Breast Cancer, mastectomy, ambulatory care

Brief summary

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 .

Interventions

breast cancer non conserving surgery

Sponsors

Centre Hospitalier de Beauvais
CollaboratorOTHER
Centre Hospitalier de Saint-Quentin
CollaboratorUNKNOWN
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
number of ambulatory care after total mastectomy allowed with PADSS scoreday 0= day of surgeryPost 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026