The Learning Curve of Total Breast Reconstruction With Autologous Fat Transfer.
Maud Rijkx, Alexander Saelmans, Juliette Hommes...
https://pubmed.ncbi.nlm.nih.gov/39016317/Actively Recruiting
Led by Maastricht University Medical Center · Updated on 2021-07-29
350
Participants Needed
8
Research Sites
N/A
Total Duration
Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer AFT with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.
CONDITIONS
AFT: Introduction of a Full Breast Reconstructive Method
J
Jamilla Wederfoort, MD, MSc
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Maastricht University Medical Center
Lead Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies depending on reconstruction process
Participants who choose to have breast reconstruction undergo Autologous Fat Transfer combined with external expansion.
Multiple visits as required for fat transfer and external expansion procedures
Duration - Up to 5 years
Participants are observed for breast-related quality of life, aesthetic results, complications, oncological safety, and cost-effectiveness.
Follow-up visits scheduled over 2 to 5 years depending on outcomes monitored
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Maud Rijkx, Alexander Saelmans, Juliette Hommes...
https://pubmed.ncbi.nlm.nih.gov/39016317/Wessel B W van der Venne, Kyrah S Goeree, Jamilla L M Wederfoort...
https://pubmed.ncbi.nlm.nih.gov/41568954/Maastricht University Medical Center
Lead Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor