Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- oncological safety
研究概览
简要总结
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
详细描述
Breast cancer is the most common cancer in women throughout the world (FerlayJ.,2010) .
The overarching principle guiding surgical management of women with breast cancer remains the oncological safety. The mainstay of satisfactory local control continues to be adequate clearance of the primary tumour and involved axillary lymph nodes. Improvements in understanding of tumour biology have enabled the risk of loco-regional recurrence and distant events to be further reduced by adjuvant, or neo-adjuvant, radiotherapy and systemic treatments. In keeping with this, breast conserving therapy has become well established as the treatment of choice for most women with early breast cancer . However, approximately one-third of women still undergo mastectomy, either due to patient preference or in cases where breast conservation is not oncologically or aesthetically compatible with the size or distribution of disease. (Reefy et al; 2010)
The primary aim of BCS is preservation of the breast while adhering to oncologic principles, with the secondary objective to provide breast aesthetics. In recent years, with advances in early detection and adjuvant therapy life expectancy has prolonged in breast cancer prolonged and quality of life issues have gained importance (Veiga DF.,2010)
Skin sparing mastectomy involves the en-bloc removal of all glandular tissue including the nipple-areola complex and in some cases adjacent biopsy scars and skin overlying superficial tumours. In contrast to conventional mastectomy, there is maximal preservation of the remaining breast skin envelope and infra-mammary fold that facilitate immediate breast reconstruction with autologous tissue and/or prosthetic implants by utilising the native skin envelope to optimise the contour, texture, colour and scarring of the reconstructed breast. (Cunnick and Mokbel; 2004).
Due to the positive results obtained in the surgical treatment of breast cancer, the prevalence of this technique is increasing throughout the world and our country. There was an approximately 2.3-fold increase in OBS publications over the last five years (Losken A et al.,2014)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals
- •For all patients an informed consent for their inclusion in the study including the use of images will be obtained.
- •Selection criteria include women with a pre-operative diagnosis (clinical examination, imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin involvement.
排除标准
- •• contraindaction for general anesthesia
- •Positive margin requiring mastectomy
- •Insufficient remaining breast volume
- •Diffuse microcalcifications
- •Multicentric tumor?
- •Inflammatory breast cancer
- •Previous radiotherapy
- •Concomitant disease ( Diabetes, smoking )
研究组 & 干预措施
oncoplastic breast surgery
This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .
干预措施: Oncoplastic breast surgery (Procedure)
结局指标
主要结局
oncological safety
时间窗: for 2 weaks
the pathological report postoperative reveals safety free margins
次要结局
- postoperative recurrence of malignany(assess for 1 year postoperative)
- mortality rate(up to 3 months postoperative for each case)
- post operative skin edge ischemia(assess for 1 month postoperative)
研究者
Alaa Mohammed Sebaiy
general surgery specialist
Assiut University