NCT04270136

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

February 12, 2020

Last Update Submit

September 12, 2023

Conditions

Breast CancerMastectomyAmbulatory Care

Keywords

Breast Cancermastectomyambulatory care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

breast cancer mastectomy

EXPERIMENTAL
Procedure: total mastectomy

Interventions

total mastectomyPROCEDURE

breast cancer non conserving surgery

breast cancer mastectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patient with an indication of breast non conserving surgery

You may not qualify if:

  • Standard contra-indication for ambulatory care.
  • Also bilateral surgery and immediate breast reconstruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Simple

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Elodie Demblocque, MD

    Centre Hospitalier de Beauvais

    PRINCIPAL INVESTIGATOR

  • Albine Mancaux, MD

    Centre Hospitalier de Beauvais

    PRINCIPAL INVESTIGATOR

  • Pierrick Theret, MD

    CH SAINT-QUENTIN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

January 1, 2021

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)