Borstreconstructies Breast cancer breast reconstruction
Conditions
Interventions
Eligible patients, who 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
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Females are included if they meet the following criteria: * 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: * 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 number of reoperations as a result of complications within the first post-operative year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: quality of life as measured by a specific breast related questionnaire (BREAST-Q), general quality of life measured with the EQ-5D, complication rate, aesthetic outcome and pain. The BREAST-Q will be administered pre-operatively and at one year after surgery, The EQ-5D is administered every 3 months to collect cost data. Based on these data QALYs will be calculated using the Dutch tariff. | — |
Countries
Netherlands
Outcome results
None listed