A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction
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
研究概览
简要总结
The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.
详细描述
This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with macromastia in oncoplastic group.
- •Tumors >20% of breast volume in oncoplastic group.
- •Young patients in oncoplastic group
- •Tumors in medial or central quadrants in oncoplastic group
排除标准
- •Patients >60 years.
- •Patients with co-morbidities in oncoplastic group.
- •Tumors >20% of breast volume in standard group.
- •Tumors in medial or central quadrants in standard group
研究组 & 干预措施
Standard Wide Local Excision group
Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .
干预措施: Standard wide local excision. (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
时间窗: Two years
次要结局
- Patient satisfaction assessed using questionnaire(two years)
研究者
Yasser Mohamed Abdel-samii
Lecturer of General surgery
Ain Shams University