Prospective, Randomized Clinical Trial Comparing Pain Sensation, Seroma Formation and Quality od Life Following BCT With SLND in Breast Cancer Patients Operated With Classic Versus High-frequency Electrocoagulation.
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain Control
研究概览
简要总结
The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-100
- •breast cancer
- •stage IIA and II B (cT1a-3; cN0-1; cM0)
- •no previous breast surgery
- •no previous cancer
- •obtained informed consent
排除标准
- •stages I, III, IV
- •localised breast infection
- •previous breast surgery for any cause
- •previous cancer
- •no voluntary consent
结局指标
主要结局
Pain Control
时间窗: From the day before surgery up to 12 weeks (+/-2days) after surgery
Pain assessment would be performed using Visual Analogue Scale (VAS) at the days 1-5, 10 (+/- 2), 20 (+/- 2), 30 (+/- 2), and 12 weeks (+/- 2 days). SF - MPQ questionnaire would be filled in on admission, 10th (+/- 2) post-operative day and 12 weeks (+/- 2 days)after surgery.
次要结局
- Quality of life (QoL)(From the day before surgery up to 12 weeks (+/-2days) after surgery)
- Length of lymphatic secretion(From the day before surgery up to 12 weeks (+/-2days) after surgery)
- Amount of lymphatic secretion(From the day before surgery up to 12 weeks (+/-2days) after surgery)
研究者
Jacek Zielinski
Assistant Profesor
Medical University of Gdansk