Immediate Breast Reconstruction's Increasing

• Conditions: Breast Cancer; Breast Reconstruction
• Interventions: Other: Comparison of complications between mastectomies with IBR and mastectomies without IBR; Other: To analyze variations of number of patients eligibles to IBR

• 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

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

Read More

Exclusion Criteria

• Prophylactic mastectomy
• Male gender

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mastectomies with IBR	Comparison of complications between mastectomies with IBR and mastectomies without IBR	Every women\>18 years who underwent mastectomies followed by IBR (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) for breast cancer in Hôpital de la Croix-Rousse between January 2016 and January 2020
Mastectomies with IBR	To analyze variations of number of patients eligibles to IBR	Every women\>18 years who underwent mastectomies followed by IBR (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) for breast cancer in Hôpital de la Croix-Rousse between January 2016 and January 2020
Mastectomies without IBR	To analyze variations of number of patients eligibles to IBR	Every women\>18 years who underwent mastectomies for breast cancer followed by delayed reconstructions (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) or no reconstructions between January 2016 and January 2020 in Hôpital de la Croix-Rousse
Mastectomies without IBR	Comparison of complications between mastectomies with IBR and mastectomies without IBR	Every women\>18 years who underwent mastectomies for breast cancer followed by delayed reconstructions (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) or no reconstructions between January 2016 and January 2020 in Hôpital de la Croix-Rousse

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