Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?
NCT ID: NCT05391763
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
21 participants
INTERVENTIONAL
2022-01-01
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Right: removal of fascia pectoralis, left: preservation of fascia pectoralis
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.
Left: removal of fascia pectoralis, right: preservation of fascia pectoralis
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Other malignancies
18 Years
80 Years
FEMALE
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Linetta Koppert
Principal Investigator
Locations
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Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Clarijs ME, van Egdom LSE, Verhoef C, Vasilic D, Koppert LB; PROFAS Collaborator Group. Bilateral prophylactic mastectomy: should we preserve the pectoral fascia? Protocol of a Dutch double blinded, prospective, randomised controlled pilot study with a within-subject design (PROFAS). BMJ Open. 2023 Feb 17;13(2):e066728. doi: 10.1136/bmjopen-2022-066728.
Other Identifiers
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NTR7620
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL72939.078.20
Identifier Type: -
Identifier Source: org_study_id
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