"Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Drainage volume after surgery
研究概览
简要总结
Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Female aged >18 years old
- •Patients that fulfill the indication of mastectomy
- •Medium-sized breast volume (Breast weight < 1500 grams)
排除标准
- •Patients who cannot complete the informed consent
- •Patients with ASA CLASS > 3
研究组 & 干预措施
Conventional electrocautery
干预措施: Conventional Electrocautery (Device)
Low thermal electrosurgery system
干预措施: Low thermal electrosurgery system (Device)
结局指标
主要结局
Drainage volume after surgery
时间窗: Up to 24 weeks
Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration
次要结局
- Wound infection(Up to 24 weeks)
- Post operative Pain(Up to 24 weeks)
- Patient's Hospital costs(up to 1 week)
研究者
Suebwong Chuthapisth
Asst. Professor
Mahidol University