Feasibility of Total Mastectomy in Ambulatory Care

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 .

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Key information

Conditions

Breast Cancer Ambulatory Care Breast Diseases Breast Neoplasms Mastectomy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Mastectomy

Procedure

breast cancer non conserving surgery

Primary outcomes

number of ambulatory care after total mastectomy allowed with PADSS score

Time frame: day 0= day of surgery

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

Centre Hospitalier de Beauvais
Centre Hospitalier de Saint-Quentin

Registry information

Acronym: AMASTEC

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Feb 17, 2020
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed