Bilateral PROphylactic mastectomy; Should we preserve the pectoral FAScia? - PROFAS 1
- Conditions
- Female BRCA 1 or 2 gene mutation carries, bilateral prophylactic mastectmy, pectoral fascia preservation, seroma production
- Registration Number
- NL-OMON22340
- Lead Sponsor
- Erasmus MC Cancer Insitute, Dpt. of Surgical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Woman > 18 years, presenting in the Academic Breast Cancer Center Rotterdam, who are opting for bilateral prophylactic mastectomy are eligible for the study.
Exclusion Criteria
Diagnosis of breast cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate to feasibility of a full-scale study.
- Secondary Outcome Measures
Name Time Method Impact of removal versus preservation of the pectoral fascia on seroma formation. Seroma is defined as any clinically detected collection of fluid requiring aspiration. The drain production and the number of days the drain will be left in situ will be measured. The volume of 30 ml in 24 hours is established as a guideline for timing of drain removal. <br /><br>Impact of removal versus preservation of the pectoral fascia on postoperative pain, wound related issues as hematoma and infection, and hospitalization duration.