Breast Reconstruction in Previously Irradiated Breast

Study Overview
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Brief Summary
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For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life. There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction. Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before. However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Official Title
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Multicenter Retrospective Evaluation Study of Pre-reconstruction Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Conditions
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Mammaplasty, Radiotherapy; Complications, Breast Implant; Complications, Transplant Failure

Intervention / Treatment
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* Radiation: Pre reconstruction Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method) Exclusion Criteria: Delayed prosthetic reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One Stage Reconstruction With pre-reconstruction Radiotherapy<br> | Radiation: Pre reconstruction Radiotherapy<br>* Previous PMRT<br>|
| Two Stage Reconstruction With pre-reconstruction Radiotherapy<br> | Radiation: Pre reconstruction Radiotherapy<br>* Previous PMRT<br>|
| Autologous Reconstruction With pre-reconstruction Radiotherapy<br> | Radiation: Pre reconstruction Radiotherapy<br>* Previous PMRT<br>|
| One Stage Reconstruction Without pre-reconstruction Radiotherapy<br> | |
| Two Stage Reconstruction Without pre-reconstruction Radiotherapy<br> | |
| Autologous Reconstruction Without pre-reconstruction Radiotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reconstruction failure | Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reconstruction Complications | Rate of need for reintervention | 2 years |