Autologous fat transfer: introduction of a full breast reconstructive method

Recruiting

Conditions: breast reconstruction
breast reconstructive surgery
10006295

Registration Number: NL-OMON55230

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

- Female gender
- Age of 18 years and older
- History or in candidate for a mastectomy procedure in the near future
- Patients undergoing preventive mastectomy
- Patients* choice to undergo a breast reconstruction
- Wanting to participate in this study
- Patient is able to wear the external expansion device

Exclusion Criteria

- Active smoker or a history of smoking 4 weeks prior to surgery
- Current substance abuse
- History of lidocaine allergy
- History of silicone allergy
- 4 weeks or less after chemotherapy
- History of radiation therapy in the breast region
- Oncological treatment includes radiotherapy after mastectomy
- Kidney disease
- Steroid dependent asthma (daily or weekly) or other diseases
- Immune-suppressed or compromised disease
- Uncontrolled diabetes
- BMI>30
- Large breast size (i.e. larger than cup C), unless the patient prefers
reduction of the contralateral side towards Cup C
- Extra-capsular silicone leaking from the encapsulated implant from a previous
breast reconstruction
- The treating plastic surgeon has strong doubts on the patient*s treatment
compliance

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The patients* quality of life will be the main outcome measure of this study,<br /><br>using the BREAST-Q questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The quality of the breast reconstruction will be measured by the volume and<br /><br>shape over time (3D photography or MRI), patient satisfaction (questionnaire)<br /><br>and aesthetic judgement (panel rating pre- and post operative photos).<br /><br>Complications during treatment and follow-up will be registered and compared.<br /><br>Oncological safety will be monitored for five years. At last, a<br /><br>cost-effectiveness analysis will be performed to research the economic<br /><br>characteristics of this new technique.</p><br>