A Comparative Study Of Using Tranexamic Acid Versus Botropase Reducing postoperative Bleeding And seroma Formation Following Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To study the effect of tranexamic acid and botropase in reduction of
研究概览
简要总结
The patients who meet the inclusion criteria will be included in the study and will receive Inj.Tranexamic acid first dose (1gm IV in 100ml Normal Saline) initially at the the time of induction of anesthesia, followed by oral tab Tranexamic acid 500mg 8 hourly for 5 days from POD1. These patients will be labelled as Group A and will be operated in the same unit in the surgery department. Breast cancer patients who are operated in other units in the department will receive Inj.botropase 2ml intravenously at the time of induction of anesthesia and followed by 2 ml intra venously 12 hourly for 5 days and will be labelled as group B. Demographic data and following data will be collected and will be analysed for the following parameters. 1 Post operative bleeding-will be measured clinically through drain placed intraoperatively or by USG guidance if needed. 2 Seroma formation- will be measured clinically through the intraoperative drain and through USG if needed. 3 Postoperative wound healing time-will be calculated from POD 1 and we will count the number of days the wound takes to heal completely and it will be assessed clinically. 4 Postoperative hospital stay- we will count the number of days the patient takes to get discharged. 5 Post operative wound infection – wound infection will be assessed by clinical symptoms like fever, pain, discharge and signs like erythema, local rise of temperature, tenderness and discharge from the wound. 6 Demography and spectrum of patients
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients giving informed consent.
- •Female patients with operable breast cancer undergoing modified radical mastectomy of age more than 18 year.
排除标准
- •• Advanced breast cancer patients in which upfront surgery is not indicated.
- •• Known thrombotic disease or high risk of thromboembolism.
- •• Patients on anticoagulants.
- •• Denial of consent.
- •• Pregnant females.
- •• Patients deemed unfit for surgery.
结局指标
主要结局
To study the effect of tranexamic acid and botropase in reduction of
时间窗: 1 week
postoperative bleeding and seroma formation in post Modified radical Mastectomy
时间窗: 1 week
patients
时间窗: 1 week
次要结局
- To reduce(Postoperative wound healing time.)
研究者
Dr Bhargav Medagani
Government Medical College, Haldwani
