Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prophylactic Mastectomy. Basic parameters: 18 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1/2 accounting for 2-5% of all breast cancer. Women with pathogenic variants in BRAC1/2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. Among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. Furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. In addition, there are established surveillance guidelines for women with pathogenic variants in BRCA1/2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. The aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.
Primary outcome measures
- Presence of residual glandular tissue [Time frame: Residual glandular tissue will be evaluated 1 year postoperatively]
- Presence of residual glandular tissue [Time frame: Residual glandular tissue will be evaluated 3 years postoperatively]
- Measurement of skin flap thickness [Time frame: Skin flap thickness will be evaluated 1 year postoperatively]
- Measurement of skin flap thickness [Time frame: Skin flap thickness will be evaluated 3 years postoperatively]
Secondary outcome measures (5)
- Change in evaluation of patient satisfaction [Time frame: Change in patient satisfaction will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.]
- Change in evaluation of patient quality of life [Time frame: Change in patient quality of life will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.]
- Number of participants with acute postoperative complications [Time frame: Clinical examination will be performed 2-4 weeks postoperatively.]
- Number of participants with long term postoperative complications [Time frame: Clinical examination will be performed 1 year postoperatively.]
- Number of participants with long term postoperative complications [Time frame: Clinical examination will be performed 3 years postoperatively.]
Eligibility criteria
Inclusion criteria
- Women that are recommended prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital due to hereditary factors that have been investigated by clinical geneticists.
- Age between 18-74 years
Exclusion criteria
- Women undergoing mastectomy due to cancer.
- Age < 18 years or > 74 years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Plastic Surgery Unit, Umeå University hospital — Umeå
Publications
- Wiberg R, Andersson MN, Svensson J, Rosen A, Koch F, Bjorkgren A, Sund M. Prophylactic Mastectomy: Postoperative Skin Flap Thickness Evaluated by MRT, Ultrasound and Clinical Examination. Ann Surg Oncol. 2020 Jul;27(7):2221-2228. doi: 10.1245/s10434-019-08157-2. Epub 2020 Jan 6. PMID 31907748
- Skoglund MA, Andersson MN, Bjorkgren A, Tolocka E, Sund M, Wiberg R. Inter- and intra-observer agreement on evaluating the presence of residual glandular tissue with magnetic resonance tomography following prophylactic mastectomy. Acta Radiol. 2023 Jan;64(1):67-73. doi: 10.1177/02841851211058929. Epub 2021 Dec 1. PMID 34851154
Identifiers
NCT: NCT05162677 · 2021-PrMa-RWiberg