跳至主要内容
临床试验/NCT02901223
NCT02901223已完成不适用

Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life

Ain Shams University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
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, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

详细描述

This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype 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

入选标准

  • Stage 1, 2 breast cancer
  • Non metastatic breast caner
  • Singing informed consent

排除标准

  • Metastatic breast cancer
  • Stage 3, 4 breast cancer
  • Inflammatory breast cancer
  • Multicentric/multifocal disease
  • Ductal carcinoma in situ
  • Patients older than 60 years
  • History of breast surgery in oncoplastic group
  • Co-morbidity in oncoplastic group
  • Patients more than 60 years old

结局指标

主要结局

Margins in all specimens measured in millimeters.

时间窗: two years.

Patient satisfaction assessed using questionnaire.

时间窗: Two years.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasser Mohamed Abdel-samii

Lecturer of general surgery

Ain Shams University

研究点 (1)

Loading locations...

相似试验