Breast cancer
Conditions
Interventions
None listed
Sponsors
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Iwate Medical University Hospital The Cancer Institute Hospital of JFCR Showa University Hospital University of Tsukuba Hospital Osaka University Hospital Yokohama City University Medical Center National Center for Child Health and Development Tokyo University of Pharmacy and Life Sciences Graduate School of Medicine, The University of Tokyo Tohoku University Hospital National Cancer Center Hospital East
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pathologically diagnosed as breast cancer. 2)Total masterectomy including Bt,SSM,NSM. 3) Breast surgeon decided the indication for breast reconstruction and immediate breast reconstruction is planned. 4)Age 20 years or more, and 75 years or less 5) ECOG Performance Status 0 or 1 6) The written informed consent has been obtained from the patients for participating in the research.
Exclusion criteria
Exclusion criteria: 1) Reconstruction for partial mastectomy 2) Cases in which total mastectomy / reconstruction was performed after partial mastectomy. 3)Cases in which ipsilateral breast reconstruction was performed before (re-reconstruction) 4) Heterochronic and simultaneous bilateral breast cancer 5) Cases in which breast appearance has remarkably changed by previous surgery such as augmentation mammoplasty before. 6) Difficult participate in the study due to complications of dementia or psychiatric symptoms 7) Cases judged by doctor to be unsuitable for study 8) Patients who do not own devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-dependent change of satisfaction with breasts score of BREAST-Q during postoperative 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The time-dependent change of satisfaction with breasts score of BREAST-Q during postoperative 36 months. BREAST-Q subscales other than satisfaction with breasts (satisfaction with implants, adverse effect of radiation, psychosocial well-being, sexual well-being, chest well-being, abdominal well-being, satisfaction of the abdomen, satisfaction with back appearance and satisfaction with functions of back and shoulders) SF-8 summary score (Physical and mental component summary) Evaluation of the burden by breast reconstruction surgery. Complication rates Evaluation of bilateral symmetry ( Harris 4 step evaluation, MammaBalance score) Recurrence rate | — |
Countries
Japan
Contacts
Public ContactMiho Saiga
Okayama university hospital Plastic surgery
Outcome results
None listed