Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

Study Overview
=================
Brief Summary
-----------------
Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.

Official Title
-----------------
Multicentic Retrospective Evaluation of Risks in Mammary Carcinoma Relapse in Patients With Mammary Reconstruction and Autologous Fat Grafting

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Autologous fat grafting procedure
* Procedure: Breast reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery group treated with lipofilling and group which didnt receive lipofilling timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up Exclusion Criteria: neoplasie different from infiltrating and in sutu breast carcinoma in situ lobular carcinoma patients with breast carcinoma and metastasis lipofilling procedure used before the oncological treatment for breast carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women receiving autologous fat grafting<br>Women who received breast reconstruction and autologous fat grafting. | Procedure: Autologous fat grafting procedure<br>* Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.<br>Procedure: Breast reconstruction<br>* Breast reconstructive procedures after oncological radical or conservative breast surgery<br>|
| Control<br>Women who received breast reconstruction only. | Procedure: Breast reconstruction<br>* Breast reconstructive procedures after oncological radical or conservative breast surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological safety of autologous fat grafting | Percentage of disease relapse in loco | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of timing in disease relapse |  | Two years | 
| Establish the distribution in disease relapses | Establish the distribution in disease relapse in thre different histological subtypes of breast carcinoma | Two years | 
| Establish overall survival rate in experimental and control groups |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous fat grafting, Lipofilling, Breast cancer, Breast reconstruction