Female BRCA 1 or 2 gene mutation carries, bilateral prophylactic mastectmy, pectoral fascia preservation, seroma production
Conditions
Interventions
A double blinded, prospective, randomized controlled pilot-study with a within-subject design, will be performed. Patients will be asked to participate at the outpatient clinic of the Erasmus MC, Canc
Sponsors
Erasmus MC Cancer Insitute, Dpt. of Surgical Oncology
Eligibility
Inclusion criteria
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
Exclusion criteria: Diagnosis of breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate to feasibility of a full-scale study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Impact of removal versus preservation of the pectoral fascia on postoperative pain, wound related issues as hematoma and infection, and hospitalization duration. | — |
Contacts
Public ContactL.B. Koppert,
Department of Surgery, Erasmus MC Cancer Institute PO Box 5201
Outcome results
None listed