196
Participants
Start Date
October 31, 2015
Primary Completion Date
October 31, 2026
Study Completion Date
October 31, 2026
autologous fat transfer
"Each procedure consists of the transfer of syringe-aspirated fat (form the abdomen, thighs, flanks) to the breast by injection in the subcutaneous planes.~Typically three separate procedures are needed for a complete breast reconstruction:~1. First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes.~2. Second session is preceeded by wearing an external pre-expansion device to prepare the recipient site for grafting. It aims to give the breast its shape and initial volume.~3. Third session is also preceded by external pre-expansion and aims to provide extra volume of the breast to achieve symmetry with the healthy breast."
breast implant
"Implant-based reconstruction typically will occur as follows:~1. During the primary mastectomy surgery, a tissue expander will be implanted subpectorally.~2. The tissue expander will be gradually filled with sterile saline during outpatient clinic visits.~3. When the desired volume is achieved, a second operation will be planned, to exchange the tissue expanded with the definite breast implant.~(Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.)"
Amstelland Hospital, Amstelveen
VU Medical Center, Amsterdam
Alexander Monro Breast cancer hospital, Bilthoven
Amphia Hospital, Breda
Ziekenhuis Groep Twente Hospital, Hengelo
Bronovo-MCH Hospital, The Hague
Maastricht University Medical Centre (MUMC+), Maastricht
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER