A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Margins in all specimens measured in millimeters 2.
研究概览
简要总结
This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and patient satisfaction.
详细描述
This planned study was conducted on 70 female patients presented to our tertiary referral breast unit at Ain Shams University hospitals with breast cancer amid the period from September 2012 to May 2013 .
Every one of them signed an informed consent to partake in this study that was approved in a meeting held by the ethical committee on august 2012 at Ain Shams University. All patients sharing in the study received closed envelope before surgery in a randomized way in which the surgical technique is written either standard conservative surgery or oncoplastic surgery(Double Blind).
Our patients were partitioned into 2 equal groups: group A (35patients) who underwent standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Patients with stage 1,2 breast cancer.
排除标准
- •Patients >60 years.
- •Patients with previous breast surgery.
- •patients candidate for mastectomy or palliative excision. Patients with collagen disease.
研究组 & 干预措施
Standard conservative group
Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .
.
干预措施: Standard conservative breast surgery (Procedure)
Oncoplastic group
Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures
干预措施: Oncoplastic breast surgery (Procedure)
结局指标
主要结局
Margins in all specimens measured in millimeters 2.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Yasser Mohamed Abdel-samii
Lecturer of General surgery
Ain Shams University