Borstreconstructies. Borstkanker breast reconstruction.
Conditions
Interventions
1. Two stage breast reconstruction after skin sparing mastectomy, with placing
of a tissue expander in the first, and implantation of a breast implant in the
second stage.
2. One stage immediate bre
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female patients from the participating hospitals are included if they meet the following criteria: willing and able to participate; aged 18 and over; able to provide informed consent and to complete questionnaires. Women who meet the inclusion criteria are informed about the study by their doctor and recieve a patientletter. There will be the possibility to ask further questions. Patients are included after signing the informed consent.
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 quality of life as measured by a specific breast related questionnaire (BREAST-Q) pre-operative and 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. In addition measure sexual health with questionaires before surgery and 12 months after surgery. 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. In addition, we look at cost-effectiveness. The esthetic outcome will be scored from pictures pre-operatively and one year post-operatively following the four point Harris breast scale (excellent-good-fair-poor) by the patient and a surgeonspanel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondly we look at the cost-effectiveness of the procedures. The cost-effectiveness using the Dutch tariff QALYs will be calculated based on the EQ-5D. | — |
Countries
Netherlands
Outcome results
None listed