Immediate Breast Reconstruction's Increasing

• Conditions: Breast Cancer; Breast Reconstruction

• Registration Number: NCT04888351
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Mastectomy in breast cancer is still a way of treatment. Nowadays, the goal is to improve reconstruction's technicals. Immediate Breast Reconstruction (IBR) is one of them, largely used in United States but less in France. However, IGR (Insitut Gustave Roussey) in Paris just wrote a new protocole wich allows more IBR by including more patients.

This study aims to compare complications in 2 groups: mastectomies followed by IBR and mastectomies without IBR. The second goal will try to estimate the proportion of eligible's patients to IBR, and to analyse their surgicals and oncologicals risk factors

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-03
• Primary Completion: 2021-04-01
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 215

Inclusion Criteria

• Over 18 years
• Breast cancer
• Mastectomy
• Hopital de la Croix-Rousse
• January 2016 and January 2020

Exclusion Criteria

• Prophylactic mastectomy
• Male gender

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global complications's rates in 2 groups (percentage)	During first year after surgery	Comparison of complications between mastectomies with IBR and mastectomies without IBR

Trial Locations

Locations (1)

Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France