Evaluation of seroma formation after Modified Radical Mastectomy using single vs double drain : a Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total duration of drain kept insitu
研究概览
简要总结
Evaluation of seroma formation after Modified Radical Mastectomy using single vs double drain. Two groups are made based on computer generated randomisation. Modified radical mastectomy done . In one group of patient, one drain placed only at the axilla. In other group, two limbs of drain is placed, one under the skin flap , other in the axilla. Seroma formation will be evaluated on the basis of drain output and number of days the drains is kept in situ. Other outcomes being evaluated are flap necrosis, surgical site infections which are all complications of seroma formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients who have biopsy proven breast cancer who are scheduled for Modified Radical Mastectomy and give valid informed consent for the study.
排除标准
- •Patients who will undergo breast conservative surgery 2)Male patients with BC.
结局指标
主要结局
Total duration of drain kept insitu
时间窗: Till 4 weeks
次要结局
- To look for flap necrosis(Till 4 weeks)
- To look for surgical site infections(Till 4 weeks)
- Pain at drain site(Till drain is insitu)
研究者
SRIJITA SAHA
Post Graduate Institute of Medical Education and Research Chandigarh
