Breast Reconstruction In One Stage

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2015
INTERVENTION: Patients whom are eligible for the study and give informed consent will be operated by a plastic surgeon. Skin sparing mastectomy and implant reconstruction will be performed in all patients. Patients will be randomized to treatment group 1 or 2 three days before the mastectomy. In treatment group 1 a tissue expander will be placed during a first surgery, and abreast prosthesis will be placed during a second surgery. In the time between the first and second surgery the tissue expander will be filled repeatedly. In treatment group 2, patients will undergo a skin sparing mastectomy with immediate placement of a breast implant combined with a collagen matrix sheet (Strattice™). CONDITION: Mastectomy, Breast reconstruction ; ; PRIMARY OUTCOME: The primary endpoint of the study is the quality of life as measured by a specific breast related questionnaire (BREAST‐Q) at one year after placement of the permanent prosthesis. This questionnaire was elected because it is especially suitable and valid for the post‐mastectomy population. SECONDARY OUTCOME: Complication rate (e.g. infection, implant loss, seroma, contraction of the breast), aesthetic outcome (as measured by a panel of experts at one year after placement of the permanent prosthesis), pain, and patient burden with regard to the number of procedures and time invested are secondary outcomes. INCLUSION CRITERIA: Females are included if they meet the following criteria: ? women with the BRCA 1/2 gen mutation who will undergo prophylactic treatment ? intended to undergo a skin sparing mastectomy ? willing and able to participate; ? aged 18 and over; ? able to provide informed consent and ? able to complete questionnaires.
Epistemonikos ID: c102428a936880323067fbe732b3ee78070676a0
First added on: Aug 23, 2024