Bilateral Prophylactic Mastectomy, BRCA1/2 Mutation, Pectoral Fascia, Seroma
Conditions
Brief summary
Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.
Detailed description
The primary objective of this pilot study is to investigate the impact of removal versus preservation of the pectoral fascia on drain policy and needle aspirations in women who undergo a bilateral prophylactic mastectomy. The secondary objective is to investigate the impact of removal versus preservation of the pectoral fascia on postoperative (surgical) complications. The study design includes a double-blinded, prospective, randomized controlled pilot study with a within-subject design. All patients will undergo a bilateral prophylactic mastectomy and randomization will occur within the patient. Preservation of the PF will be performed in one breast (intervention), while removal of the PF will be performed in the contralateral breast of the same patient (control). Consequently, the operation involves a total bilateral prophylactic mastectomy, with unilateral preservation of the PF The follow-up time of each patient will be 6 weeks. The patients' files will be viewed after the removal of the drain for additional recorded variables.
Interventions
PROCEDUREFascia pectoralis preservation
A total mastectomy will be performed in the control breast: a procedure which includes removal of the breast glandular tissue including the PF and subcutaneously excision of the nipple-areolar complex, while the pectoralis muscle will be spared. As much of the healthy skin envelope will be preserved to enable the performance of an effective breast reconstruction afterwards. When a nipple-sparing mastectomy is performed, the skin envelope together with the nipple-areolar complex will be spared. The investigational part of the operation is preservation of the PF. Dissection of cutaneous flaps and the breast with or without the PF will be performed with electrocautery.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The patient and the observer for drain volume are both blinded for their assigned breast randomization. The surgeon(s) and coordinating researcher will not be blinded, and are therefore not allowed to measure the drain production.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female patient * Scheduled for a bilateral prophylactic mastectomy in the Erasmus MC Academic Breast Cancer Centre in Rotterdam * Ability to give written consent * Adequate understanding of Dutch language
Exclusion criteria
* History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS) * Other malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drainproduction in milliliters | Until drain removal, maximum 1 week | The total drainage volume of the left and right breast in milliliters |
| Time to drain removal in days | Until drain removal, maximum 1 week | Number of days until drain removed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain (score 1-10) | Up to 6 weeks | Postoperative pain measured with Visual Analogue Scale |
| Postoperative bleeding (yes/no) | Up to 6 weeks | Occurrence of postoperative bleeding |
| Seroma (yes/no) | Up to 6 weeks | Occurrence of seroma |
| Hospitalization duration (in days) | Up to 6 weeks | Duration of hospitalization, including readmissions |
| Wound related issues (yes/no) | Up to 6 weeks | Wound related issues such as hematoma or infection |
| Needle aspirations (number) | Up to 6 weeks | Number of needle aspirations |
Countries
Netherlands
Contacts
Primary ContactMarloes Clarijs, MD
Outcome results
None listed