Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

Not Applicable

Recruiting

• Conditions: Seroma; Bilateral Prophylactic Mastectomy; BRCA1/2 Mutation; Pectoral Fascia
• Interventions: Procedure: Fascia pectoralis preservation

• Registration Number: NCT05391763
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right: removal of fascia pectoralis, left: preservation of fascia pectoralis	Fascia pectoralis preservation	-
Left: removal of fascia pectoralis, right: preservation of fascia pectoralis	Fascia pectoralis preservation	-

Primary Outcome Measures

Name	Time	Method
Drainproduction in milliliters	Until drain removal, maximum 1 week	The total drainage volume of the left and right breast in milliliters
Time to drain removal in days	Until drain removal, maximum 1 week	Number of days until drain removed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands