Bilateral prophylactic mastectomy; Should we preserve the pectoral fascia?

Bilateral prophylactic mastectomy; Should we preserve the pectoral fascia? - PROFAS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49867

Enrollment

Registered

2020-12-18

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA mutation carriers

Interventions

All patients will undergo a bilateral prophylactic mastectomy. Randomization will occur within the patient, with each breast randomized between preservation and removal of the pectoral fascia

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female and age 18 years or older - Scheduled for bilateral prophylactic mastectomy

Exclusion criteria

Exclusion criteria: Diagnosis of breast cancer

Design outcomes

Primary

Measure	Time frame
Impact of removal versus preservation of the pectoral fascia on seroma formation. 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. Seroma is defined as any clinically detected collection of fluid requiring aspiration.The number of needle aspirations and volume in ml will be reported.	—

Measure

Time frame

Impact of removal versus preservation of the pectoral fascia on seroma formation. 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. Seroma is defined as any clinically detected collection of fluid requiring aspiration.The number of needle aspirations and volume in ml will be reported.

—

Secondary

Measure	Time frame
Impact of removal versus preservation of the pectoral fascia on postoperative pain, wound related issues as hematoma and infection, and hospitalization duration will be reported.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)