Immediate Breast Reconstruction's Increasing

Mastectomy and Breast Cancer : Follow-up of IBR's Rate and Study of Complications as Compared to Delayed Reconstructions Between 2016 and 2020 in Lyon

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04888351

Acronym

IBRI

Enrollment

215

Registered

2021-05-17

Start date

2021-01-01

Completion date

2021-06-30

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Reconstruction

Keywords

Immediate Breast Reconstruction (IBR), Mastectomy, Breast cancer

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

Interventions

OTHERComparison of complications between mastectomies with IBR and mastectomies without IBR

Precocious complications (less than 3 months after surgery) are classified with Clavien's classification : hematoma, seroma, stitches, antibiotics, transfusion. Tardive complications (after 3 months until 1 year) are more specifics : hematoma, seroma, tardive infections, asymmetry, removing of implant, breaking up of implant, skin necrosis, capsular contractures, implant loss, chronic pain.

OTHERTo analyze variations of number of patients eligibles to IBR

Including patients with differents classic risk factors : T3, T4, tobacco, diabetes, overweight and obesity, hypertension, age over 70, thoracic irradiation in the past

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Prophylactic mastectomy * Male gender

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactMarion CORTET, MD

marion.cortet@chu-lyon.fr4 27 85 40 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026