RESUMEN
BACKGROUND: A causal relation between systemic symptoms and breast implants has not been established. Psychological factors, such as personality and psychological distress, are strongly associated with the development of medically unexplained symptoms. It can be hypothesized that psychological factors may be related to the development of breast implant illness (BII). OBJECTIVES: This study was conducted to evaluate the correlation between self-reported health complaints, health- and breast-related quality of life (QoL), and personality, in women with cosmetic breast implants. METHODS: Women who attended the plastic surgery outpatient clinic of Maastricht University Medical Center between October 2020 and October 2021 for reasons related to their implants and women recruited for a BII study at the Center during this period were invited to participate in this study. Only women who underwent cosmetic breast augmentation were eligible. Participants completed a physical complaints score form and the BREAST-Q, SF-36, and EPQ-RSS questionnaires via an online survey. RESULTS: In total, 201 women completed the questionnaires. Extroversion and social desirability were predominant personality traits in women with breast implants, followed by neuroticism. Relatively high levels of neuroticism were found compared with normative data. Neuroticism correlated significantly with health status and breast-related QoL. Physical and mental health-related QoL had the strongest correlations with neuroticism (ß = -3.94, ß = -4.86, P < 0.001). CONCLUSIONS: Personality can play a role in the development of complaints. High levels of neuroticism are seen in cosmetic surgery patients and are negatively correlated with subjective health and patient-reported outcomes in women with breast implants. Therefore, neuroticism may be a factor in the development of BII.
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Implantes de Mama , Humanos , Femenino , Implantes de Mama/efectos adversos , Calidad de Vida/psicología , Personalidad , Neuroticismo , Encuestas y CuestionariosRESUMEN
BACKGROUND: With developments in screening and treatment, survival rates of breast cancer patients are increasing, and so is the number of women opting for breast reconstruction to improve their quality of life. One factor that could play an important role in improving the quality of life is breast sensibility. Therefore, the aim of this study was to explore breast sensibility in participants of the Breast Reconstruction with External Preexpansion and Autologous Fat Transfer versus Standard Therapy trial: an ongoing randomized controlled trial comparing breast reconstruction with autologous fat transfer (AFT) versus implant-based reconstruction (IBR). METHODS: This study was conducted on participants of the Breast Reconstruction with External Preexpansion and Autologous Fat Transfer versus Standard Therapy trial who were at least 12 months after final surgery. Semmes-Weinstein monofilaments were used to measure skin sensibility in breast cancer patients who underwent breast reconstruction with either AFT or IBR following their mastectomy. RESULTS: A total of 46 patients were included in this study, resulting in 62 breast reconstructions (28 AFT breasts and 34 IBR breasts). Significantly higher mean monofilament values were found for skin sensibility after AFT (-0.7; P < 0.001), clinically correlating to "diminished protective function," as opposed to the IBR group, with clinical values indicating "loss of protective function." CONCLUSIONS: In this study, the authors found that breast cancer patients who underwent a mastectomy had a significantly better sensibility of the breast following AFT for total breast reconstruction as compared with IBR. Larger studies that include null measurements are required to further explore these noteworthy results of AFT. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
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Neoplasias de la Mama , Mamoplastia , Femenino , Humanos , Mama/cirugía , Neoplasias de la Mama/cirugía , Mamoplastia/métodos , Mastectomía/métodos , Calidad de Vida , Estudios Retrospectivos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Importance: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. Objective: To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). Design, Setting, and Participants: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. Interventions: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. Main Outcomes and Measures: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. Results: A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found. Conclusions and Relevance: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02339779.
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Implantes de Mama , Neoplasias de la Mama , Mamoplastia , Femenino , Humanos , Persona de Mediana Edad , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/etiología , Mastectomía/métodos , Calidad de Vida , Satisfacción del Paciente , Mamoplastia/métodosRESUMEN
INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.
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Neoplasias de la Mama , Mamoplastia , Mama/cirugía , Femenino , Humanos , Mastectomía , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
OBJECTIVES: Numerous studies have shown that breast reconstruction after mastectomy improves QoL in breast cancer survivors. However, still about half of the patients does not opt for reconstruction. In order to accommodate suitable counseling, we should elucidate the factors that play a role in the decision-making process. This study aimed to evaluate the influence of QoL, among women diagnosed with breast cancer before the start of any treatment, on their decision whether or not to undergo breast reconstruction. MATERIALS AND METHODS: BREAST-Q surveys were provided to breast cancer patients at the specialized breast care outpatient clinic after their first consultation with a surgical oncologist, between June 2017 and March 2019. The Q-scores of the subdomains physical well-being, psychosocial well-being, sexual well-being, and satisfaction with breasts of patients that underwent mastectomy were statistically analyzed. RESULTS: Sixty-seven patients, undergoing mastectomy, completed the questionnaire. Fifty-four percent received reconstructive surgery. Mean age of patients seeking breast reconstruction was significantly lower than patients who did not opt for a reconstruction (53.5 vs. 63.7). Mean follow-up after mastectomy was 18.1 months. Except for satisfaction with breasts, mean Q-scores were higher in the group of patients who did not choose for reconstructive surgery. Psychosocial well-being was significantly higher in the non-reconstruction group (pâ¯=â¯0.012). CONCLUSIONS: Psychosocial well-being at time of diagnosis of breast cancer was significantly higher in patients refraining from breast reconstructive surgery after mastectomy. Psychosocial characteristics might be essential for the decision-making process as well. Further prospective research should evaluate this.
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Neoplasias de la Mama/cirugía , Toma de Decisiones , Mamoplastia/psicología , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/psicología , Femenino , Humanos , Mastectomía , Persona de Mediana Edad , Medición de Resultados Informados por el Paciente , Calidad de VidaRESUMEN
BACKGROUND: Autologous fat transfer (AFT), also known as lipofilling, has been demonstrated to be more than just a filler. Through both mechanical dissection and local tissue remodelling mediated by stem cells, it is thought to improve scar quality, function and even pain. This paper aims to investigate the evidence regarding its safety and effectiveness for treating fibrosis and scar-related conditions. METHODS: A literature search was performed in PubMed, Embase and the Cochrane Library to identify relevant studies. Extensive data extraction and standardization allowed conducting a meta-analysis. RESULTS: Forty-five studies (3033 patients) provided sufficient data for meta-analysis. The AFT treatment resulted in significant increase in satisfaction scores of both patient and surgeon (p⯠= â¯0.001). Furthermore, a significant overall scar improvement was also found in the evaluation using the Patient and Observer Scar Assessment Scale, with the most notable effect in the scar stiffness (p<0.001) and pliability (p⯠= â¯0.004). In patients with severe pain, AFT resulted in a significant pain reduction of 3.7 points on the Visual Analogue Scale (p<0.001). Last, but not the least, the evidence suggests a significant recovery of radiotherapy-induced tissue damage (p⯠= â¯0.003) and function (p⯠= â¯0.012). On average, 1.4 procedures were required to achieve the desired result. Minor complications occurred in 4.8% of the procedures. CONCLUSIONS: AFT is a promising treatment for fibrosis and scar-related conditions. Future research should focus on determining the long-term effects of AFT on fibrosis, pain and function. In addition, it would be crucial to quantify the mechanical and regenerative properties of fat as well as the effect of added supplements or stem cells.