Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

Seroma Clinical Trial

— PROFAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391763
• Other study ID #: NL72939.078.20
• Secondary ID: NTR7620
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Erasmus Medical Center
• Contact: Marloes Clarijs, MD
• Phone: +31 6 22035529
• Email: m.clarijs[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1/2 Mutation
• Seroma

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drainproduction in milliliters	The total drainage volume of the left and right breast in milliliters	Until drain removal, maximum 1 week
Primary	Time to drain removal in days	Number of days until drain removed	Until drain removal, maximum 1 week
Secondary	Seroma (yes/no)	Occurrence of seroma	Up to 6 weeks
Secondary	Needle aspirations (number)	Number of needle aspirations	Up to 6 weeks
Secondary	Postoperative pain (score 1-10)	Postoperative pain measured with Visual Analogue Scale	Up to 6 weeks
Secondary	Postoperative bleeding (yes/no)	Occurrence of postoperative bleeding	Up to 6 weeks
Secondary	Wound related issues (yes/no)	Wound related issues such as hematoma or infection	Up to 6 weeks
Secondary	Hospitalization duration (in days)	Duration of hospitalization, including readmissions	Up to 6 weeks