Feasibility of Total Mastectomy in Ambulatory Care

NCT ID: NCT04270136

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-09-12

Brief Summary

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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 .

Detailed Description

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Conditions

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Breast Cancer Mastectomy Ambulatory Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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breast cancer mastectomy

Group Type EXPERIMENTAL

total mastectomy

Intervention Type PROCEDURE

breast cancer non conserving surgery

Interventions

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total mastectomy

breast cancer non conserving surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Beauvais

OTHER

Sponsor Role collaborator

Centre Hospitalier de Saint-Quentin

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elodie Demblocque, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Beauvais

Albine Mancaux, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Beauvais

Pierrick Theret, MD

Role: PRINCIPAL_INVESTIGATOR

CH SAINT-QUENTIN

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2018_843_0061

Identifier Type: -

Identifier Source: org_study_id

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