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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    21
  • sponsor
    Erasmus Medical Center
Updated on 3 June 2022
cancer

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.

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.

Details
Condition BRCA1/2 Mutation, Bilateral Prophylactic Mastectomy, Seroma, Pectoral Fascia
Treatment Fascia pectoralis preservation
Clinical Study IdentifierNCT05391763
SponsorErasmus Medical Center
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patient
Scheduled for a bilateral prophylactic mastectomy

Exclusion Criteria

History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
Other malignancies
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