Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- breast image scale
研究概览
简要总结
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
- •BIRADS IV, V or VI are eligible
- •> 18 years of age
- •Psychological and physical capable of understanding and performing the trial
- •Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant
排除标准
- •Inflammatory breast cancer
- •Progression after neoadjuvant therapy
- •Pregnant women
- •Patients unable to perform surgery under general anaesthesia
- •Bilateral breast lesions
结局指标
主要结局
breast image scale
时间窗: 2 years
self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.
次要结局
- Morbidity(6 months)
- breast symmetry index(2 years)
- oncologic parameters(2-5 years)
- quality of life(2 years)
研究者
Florian Fitzal
Professor of Surgery
Medical University of Vienna