- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270136
Feasibility of Total Mastectomy in Ambulatory Care (AMASTEC)
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 .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arthur Foulon, MD
- Phone Number: (33)3 22 66 88 20
- Email: foulon.arthur@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
Contact:
- Arthur Foulon, MD
- Phone Number: (33)3 22 66 88 20
- Email: foulon.arthur@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: breast cancer mastectomy
|
breast cancer non conserving surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
day 0= day of surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elodie Demblocque, MD, Centre Hospitalier de Beauvais
- Principal Investigator: Albine Mancaux, MD, Centre Hospitalier de Beauvais
- Principal Investigator: Pierrick Theret, MD, CH Saint Quentin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2018_843_0061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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