BRALAV-study: Breast Reconstruction; Added Layer, Added Value?
Withdrawn
- Conditions
- BorstreconstructiesBreast cancerbreast reconstruction10006295
- Registration Number
- NL-OMON40855
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 100
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is the number of reoperations as a result of<br /><br>complications within the first post-operative year</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are: quality of life as measured by a specific breast<br /><br>related questionnaire (BREAST-Q), general quality of life measured with the<br /><br>EQ-5D, complication rate, aesthetic outcome and pain. The BREAST-Q will be<br /><br>administered pre-operatively and at one year after surgery, The EQ-5D is<br /><br>administered every 3 months to collect cost data. Based on these data QALYs<br /><br>will be calculated using the Dutch tariff.</p><br>