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r> Previous prospective short-term follow-up studies have shown high overall cosmetic satisfaction six months and one year post-RRM, corresponding to the women's expectations, and no nega-tive impact on anxiety/depressive symptoms, or HRQoL [7,8]. Body image and sexuality were negatively affected the first years after surgery [9e12]. Long-term effects of risk-reducing surgery have
been studied retrospectively, indicating high procedure satisfac-tion, but decreased levels of satisfaction with the physical appear-ance [13e17]. There is, however, a lack of long-term prospective psychosocial follow-up studies [17].
This prospective follow-up study aimed to investigate women's perceptions of the cosmetic outcome of their breast reconstruction, body image, sexuality, anxiety/depressive symptoms, and HRQoL, 6e20 years post-RRM. Differences between women with or without previous breast cancer at follow-up, as well as changes over time from the one-year assessment to follow-up, were evaluated.
2. Material and methods
2.1. Patients and procedure
Between March 1997 and September 2010, 298 women under-went RRM at Karolinska University Hospital in Stockholm, Sweden due to increased hereditary risk for breast cancer. Individual risk for breast cancer was based on BRCA tests/family history of breast cancer. A total of 188 (63%) ‘women without cancer’ underwent bilateral RRM, while 110 (37%) ‘women with (previous breast) cancer’ underwent complementary/contralateral RRM (depending on if they Trehalose 6-phosphate previously had breast conservation or mastectomy). No women underwent risk-reducing surgery concomitantly with their cancer surgery. The RRM was performed at a mean time of 56 (range 16e254) months after breast cancer surgery. Ninety-five percent had IBR with expandable or permanent implants, placed under total muscular cover. At the time of surgery, the most com-mon procedure was removal of the nipples and subsequent regrafting or with other techniques. Surgical details have been described in our previous studies [10,11,18].
We started a prospective psychosocial follow-up study in connection to RRM in 1997, and short-term results have been published [8e10]. No power calculations were made since syphilis was not planned in the initial study design in 1997. The previously collected psychosocial questionnaire data from the same in-struments used in the current study were available in a database, including the responses of the eligible 200 women. Women declining future participation in data collection, and those diag-nosed with breast/other cancer(s) after RRM were excluded from the present study.
An information letter regarding the current follow-up study was sent to the women's home addresses during NovembereDecember 2016. An informed consent form asking for permission to review medical records in order to investigate clinical aspects post-RRM, the questionnaires, and a prepaid return envelope were also attached. One reminder was sent if no answer was obtained after one month, the last were sent January 2017. Questionnaire-data collection proceeded until May 31, 2017. After completion, the participants sent questionnaires and consent forms via the prepaid envelope to the study coordinator (LB) at the Department of Oncology-Pathology, Karolinska Institutet.
The European Organisation for Research and Treatment of Cancer Breast Reconstruction Questionnaire (EORTC QLQ-BRR26) assesses satisfaction with the results after breast reconstruction. The questionnaire was validated/tested for reliability in a set of breast cancer patients after breast reconstruction [19,20]. It consists of 26 items constituting three scales with scores ranging from 1 (‘Not at all’) to 4 (‘A lot’). The Swedish version has been formally translated, and was a part of the development of this questionnaire [19,20].