Clinical trial NCT05391763: Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?
Official title: Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?: Protocol of a Dutch Double Blinded, Prospective, Randomized Controlled Pilot Study With a Within-subject Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BRCA1/2 Mutation
Bilateral Prophylactic Mastectomy
Seroma
Pectoral Fascia
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drainproduction in milliliters
timeFrame: Until drain removal, maximum 1 week
measure: Time to drain removal in days
timeFrame: Until drain removal, maximum 1 week
Secondary outcomes:
measure: Seroma (yes/no)
timeFrame: Up to 6 weeks
measure: Needle aspirations (number)
timeFrame: Up to 6 weeks
measure: Postoperative pain (score 1-10)
timeFrame: Up to 6 weeks
measure: Postoperative bleeding (yes/no)
timeFrame: Up to 6 weeks
measure: Wound related issues (yes/no)
timeFrame: Up to 6 weeks
measure: Hospitalization duration (in days)
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: