Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 主要终点
- seroma formation
研究概览
简要总结
Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage.
The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.
详细描述
Modified Radical mastectomy is commonly performed procedure for carcinoma breast. After surgery two drains are placed, one in axilla and one beneath the flap. The use of two drains is associated with significant post operative discomfort and pain. On the other hand two drains have not been proven to decrease post operative seroma formation.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All female patients underwent MRM for biopsy proven carcinoma breast
排除标准
- •Immediate reconstruction
- •Patient refusal to participate in study
结局指标
主要结局
seroma formation
时间窗: 30 days post surgery
fluid collection beneath the flap sufficient to cause patient discomfort and pain
次要结局
- wound infection(30 days after surgery)
- flap necrosis(30 days after surgery)
- Duration of hospital stay,,(30 days after surgery)
- hematoma(30 days after surgery)
- postoperative pain(30 days after surgery)
研究者
salma khan
Consultant General Surgeon
Memon Medical Institute