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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Seroma; BRCA1/2 Mutation; Bilateral Prophylactic Mastectomy; Pectoral Fascia
• Intervention / Treatment: Procedure: Fascia pectoralis preservation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marloes Clarijs, MD; Phone Number: +31 6 22035529; Email: m.clarijs@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: Linetta Koppert, MD, PhD, MHS; Phone Number: +31107040151; Email: l.koppert@erasmusmc.nl
    • Principal Investigator: Linetta Koppert, MD, PhD, MHS
    • Sub-Investigator: Dalibor Vasilic, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Right: removal of fascia pectoralis, left: preservation of fascia pectoralis	Procedure: Fascia 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.
Other: Left: removal of fascia pectoralis, right: preservation of fascia pectoralis	Procedure: Fascia 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: NL72939.078.20; NTR7620 (Registry Identifier: trialregister.nl)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No