Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Duration of drains (days)
研究概览
简要总结
To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.
详细描述
In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females with biopsy proven breast cancer underwent MRM
排除标准
- •Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
研究组 & 干预措施
Electrocautery
Raising of the flaps with electrocautery
干预措施: electrocautery (Procedure)
Harmonic
Dissection with harmonic scalpel in modified radical mastectomy
干预措施: Harmonic (Device)
结局指标
主要结局
Duration of drains (days)
时间窗: 30 days
Durations of drains in place after MRM: Patients were followed in clinic every 3rd day and drains were removed once the volume was \<30ml a day.
次要结局
- Pain(24 hours)
- Drain Volume(30 days)
- Overall complications(30 days)
- Operative time(3-4 hours)
研究者
Ghulam Murtaza
Co Principal Investigator
Aga Khan University