Breast Reconstruction In One Stage
Completed
- Registration Number
- NL-OMON27085
- Lead Sponsor
- VUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
Females are included if they meet the following criteria:
▪ women with the BRCA 1/2 gen mutation who will undergo prophylactic treatment
Exclusion Criteria
Exclusion criteria are:
▪ women with a body mass index > 30
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.