Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

Study Overview
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Brief Summary
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The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant. Our aims are: To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not. Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.

Detailed Description
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All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this. Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis. Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately. After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.

Official Title
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Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Autologous fat transplantation
* Procedure: Expander prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously undergone mastectomy and adjuvant radiotherapy. Will undergo breast reconstruction with expander prosthesis. Mammogram and ultrasound performed maximum three month prior surgery. At least one year since last operation or radiotherapy. Exclusion Criteria: Known breast cancer relapse Distant metastases except axillary Any contraindication for anaesthesia Systemic disease such as diabetes mellitus type I. BMI >30 (if the patients lose weight they are eligible)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast reconstruction with implant<br>The patients will undergo breast reconstruction with an expander prosthesis. | Procedure: Expander prosthesis<br>* breast reconstruction with expander prosthesis.<br>* Other names: implant;|
| Experimental: Autologous fat transplantation<br>The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis. | Procedure: Autologous fat transplantation<br>* 100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis.<br>* Other names: lipomodelling;Procedure: Expander prosthesis<br>* breast reconstruction with expander prosthesis.<br>* Other names: implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of reoperations |  | Two years on from reconstruction with prosthesis | 
| Frequency of complications |  | Two years on from reconstruction with prosthesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total days in hospital during fat transplantation and reconstruction with prosthesis | Number of days spent at the hospital for surgery including both day surgery with fat transplantation and reconstruction with prosthesis. | 4 month | 
| Number of appointments as outpatient after breast reconstruction. | Number of appointments with surgeon and nurse as outpatient after the reconstructive surgery is performed. | Two years on from reconstruction with prosthesis | 
| Aesthetic evaluation of the results of the breast reconstruction | Aesthetic outcome is evaluated by plastic surgeons through assessment of standardized photographies of the patients. | Two years on from reconstruction with prosthesis | 
| Patient reported outcome | Breast Q is a validated questionnaire for quality of life | Measured at 6, 12 and 24 month from reconstruction with prosthesis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammaplasty, Transplantation, Autologous, Mastectomy, Breast Implants, Radiotherapy, Adjuvant