Status:

UNKNOWN

Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?

Lead Sponsor:

Erasmus Medical Center

Conditions:

BRCA1/2 Mutation

Bilateral Prophylactic Mastectomy

Eligibility:

FEMALE

18-80 years

Phase:

NA

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 mastectom...

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 pro...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

January 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT05391763

Start Date

January 1 2022

End Date

December 1 2023

Last Update

January 11 2023

Active Locations (1)

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1

Erasmus Medical Center

Rotterdam, Netherlands