Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Study Overview
=================
Brief Summary
-----------------
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. Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction. However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction. In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.

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

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

Intervention / Treatment
-----------------
* Radiation: Adjuvant Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
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 capsular contracture and rate of need for reintervention | 2 years |