Skin sparing mastectomy with implant reconstruction is frequently applied in breast cancer patients. Psychological outcome greatly improves when immediate breast reconstruction is performed after mastectomy. However, due to inadequate soft tissue coverage of the implant current direct implant procedures after skin sparing mastectomy are ineffective and often lead to revision surgery. Hence, a two-stage procedure, where tissue expanders are used as a first step and definitive implants are placed
Conditions
Interventions
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
Sponsors
VUMC
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: ▪ women with a body mass index > 30 ▪ woman who need a too large breast size according to the specialist ▪ woman who receive a polyurethaan implant ▪ women who did not quit smoking two weeks before surgery ▪ oncologic patients who have to receive post-operative radiotherapy ▪ pregnancy or planning a pregnancy during the study; ▪ ongoing severe psychiatric illness or mental retardation; ▪ evidence of alcohol and/or drug abuse; ▪ inability to complete the questionnaires; ▪ local or general infection which could jeopardize the surgical objective; ▪ extensive local inflammatory reactions; ▪ proven or suspected hypersensitivity to materials; ▪ immunosuppressive pathologies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactRieky E. Dikmans
VU University Medical Center - Dept. of plastic, reconstructive and hand surgery - Room Z4D130
Outcome results
None listed