Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

NAUnknownINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

December 1, 2023

Study Completion Date

December 1, 2023

Conditions
BRCA1/2 MutationBilateral Prophylactic MastectomySeromaPectoral Fascia
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER