Feasibility of Total Mastectomy in Ambulatory Care

Breast Cancer Clinical Trial

— AMASTEC  

Official title:

Feasibility of Total Mastectomy in Ambulatory Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270136
• Other study ID #: PI2018_843_0061
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Ambulatory Care
• Breast Cancer
• Breast Neoplasms
• Mastectomy

Intervention

Procedure:
• total mastectomy
breast cancer non conserving surgery

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Beauvais, Centre Hospitalier de Saint-Quentin

Country where clinical trial is conducted

France, 

Outcome

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