Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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BRCA1/2 Mutation, Bilateral Prophylactic Mastectomy, Seroma, Pectoral Fascia

Intervention / Treatment
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* Procedure: Fascia pectoralis preservation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Right: removal of fascia pectoralis, left: preservation of fascia pectoralis<br> | Procedure: Fascia pectoralis preservation<br>* 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.<br>|
| Other: Left: removal of fascia pectoralis, right: preservation of fascia pectoralis<br> | Procedure: Fascia pectoralis preservation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drainproduction in milliliters | The total drainage volume of the left and right breast in milliliters | Until drain removal, maximum 1 week | 
| Time to drain removal in days | Number of days until drain removed | Until drain removal, maximum 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma (yes/no) | Occurrence of seroma | Up to 6 weeks | 
| Needle aspirations (number) | Number of needle aspirations | Up to 6 weeks | 
| Postoperative pain (score 1-10) | Postoperative pain measured with Visual Analogue Scale | Up to 6 weeks | 
| Postoperative bleeding (yes/no) | Occurrence of postoperative bleeding | Up to 6 weeks | 
| Wound related issues (yes/no) | Wound related issues such as hematoma or infection | Up to 6 weeks | 
| Hospitalization duration (in days) | Duration of hospitalization, including readmissions | Up to 6 weeks |