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

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05391763

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
BRCA1/2 Mutation Bilateral Prophylactic Mastectomy Seroma Pectoral Fascia	Procedure: Fascia pectoralis preservation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

The patient and the observer for drain volume are both blinded for their assigned breast randomization. The surgeon(s) and coordinating researcher will not be blinded, and are therefore not allowed to measure the drain production.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

Seroma (yes/no) [Up to 6 weeks]
Occurrence of seroma
Needle aspirations (number) [Up to 6 weeks]
Number of needle aspirations
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patient
Scheduled for a bilateral prophylactic mastectomy

Exclusion Criteria:

History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
Other malignancies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Linetta Koppert, Principal Investigator, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT05391763

Other Study ID Numbers:

NL72939.078.20
NTR7620

First Posted:

May 26, 2022

Last Update Posted:

May 26, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Seroma

Study Results

No Results Posted as of May 26, 2022