Tailoring Surgical Management of Multifocal Breast Cancer:is There a Possibility
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Recurrence of the Tumor
研究概览
简要总结
Multi-focal Breast Cancers(MFBC) still have undiscoverable Clinical Significance reflecting on a debatable surgical decision for this Category of breast cancer. A prospective study was conducted using certain surgical technique as a surgical treatment for female patients with operable breast cancer managed at the Surgical Oncology Unit, Alexandria University from May. 2017 to May2018 and will be followed for 3 Years.Analysis will be done to settle a paradigm for surgical management of Multi-focal Breast Cancer
详细描述
- Age at diagnosis: young patients are defined as younger than 35 years.
- Surgical techniques: Preoperatively all patients will undergo physical examination of both breasts and axillae as well as bilateral mammograms and ultrasonography of both breasts. Histopathological diagnosis of cancer will be made prior to surgery. The planned procedure will be discussed. Different oncoplastic techniques will be utilized to achieve oncologically appropriate margins with either sentinel lymph node detection or axillary lymph node dissection according to the triple assessment of the patients . Surgical margins were determined by macroscopic and histologic examination of frozen sections of the breast specimens in the operating room. An adequate safety margin of 1cm was always insured. Breast remodeling will be done according to breast size, degree of ptosis and size of defect.
- Tumor characteristics: size, nodal status, presence of lympho-vascular invasion, amount of intraductal component, tumor grade, margin status, hormone receptor, and Her2 neu status.
- Margins will be regarded as negative when permanent histological examination found no ink on the tumor.
- Postoperative surgical complications will be documented if happened; seroma formation, hematoma and or wound dehiscence.
- Cosmetic outcome: The postoperative esthetic result will be evaluated asking the patients to rate the postoperative cosmetic result and their degree of satisfaction compared to the preoperative breast using a five-point scale (excellent, 5; good, 4; fair, 3; poor, 2;bad, 1). Objective assessment of the cosmetic result was done by two surgeons, rated on a visual analog scale from 1 (unacceptable result) to 10 (excellent result). Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. (14)
- The occurrence of loco-regional recurrence or distant metastases during the follow-up period was recorded and considered as an end point for follow-up.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all operable female patients affected with multifocal breast cancer
排除标准
- •inflammatory breast cancer
- •patients need receiving neoadjuvant therapy
结局指标
主要结局
Recurrence of the Tumor
时间窗: a median of 30 months post operative
assessment of the occurrence of local or distant recurrence through: 1. monthly clinical examination of both breast and axillae 2. monthly liver functions tests and complete blood count 3. radiological assessment if clinically indicated
次要结局
- Cosmetic Result(a median of 30 months post operative)
研究者
mostafa mohamed elsayed
registrar of surgical oncology and general surgery
Alexandria University