Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia? (PROFAS)

Erasmus University

Status: Enrolling

Conditions: Pectoral Fascia; Bilateral Prophylactic Mastectomy; Seroma; BRCA1/2 Mutation

Treatments: Procedure: Fascia pectoralis preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT05391763

NTR7620 (Registry Identifier)

NL72939.078.20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Right: removal of fascia pectoralis, left: preservation of fascia pectoralis

Other group

Treatment:

Procedure: Fascia pectoralis preservation

Left: removal of fascia pectoralis, right: preservation of fascia pectoralis

Other group

Treatment:

Procedure: Fascia pectoralis preservation