Feasibility of Total Mastectomy in Ambulatory Care

Not Applicable

Completed

• Conditions: Ambulatory Care; Breast Cancer; Mastectomy
• Interventions: Procedure: total mastectomy

• Registration Number: NCT04270136
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2021-01-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
breast cancer mastectomy	total mastectomy	-

Primary Outcome Measures

Name	Time	Method
number of ambulatory care after total mastectomy allowed with PADSS score	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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France