Bilateral prophylactic mastectomy; Should we preserve the pectoral fascia?

• Conditions: BRCA mutation carriers; 10006291; 10006295

• Registration Number: NL-OMON49867
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

Diagnosis of breast cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Impact of removal versus preservation of the pectoral fascia on seroma<br /><br>formation. The drain production and the number of days the drain will be left<br /><br>in situ will be measured. The volume of 30 ml in 24 hours is established as a<br /><br>guideline for timing of drain removal. Seroma is defined as any clinically<br /><br>detected collection of fluid requiring aspiration.The number of needle<br /><br>aspirations and volume in ml will be reported.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Impact of removal versus preservation of the pectoral fascia on postoperative<br /><br>pain, wound related issues as hematoma and infection, and hospitalization<br /><br>duration will be reported. </p><br>