Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
试验速览
- 阶段
- 1 期
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Venous thrombosis and/or pulmonary embolism (PE)
研究概览
简要总结
Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.
详细描述
Two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI >40 OR >35 with comorbidities
排除标准
- 未提供
研究组 & 干预措施
ENOXAPARIN 2 HOURS BEFORE
Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
干预措施: Enoxaparin 40 mg 2 hours before arm (Drug)
ENOXAPARIN 2 HOURS BEFORE
Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
干预措施: Enoxaparin 40 mg 12 hours before arm (Drug)
Enoxaparin 40 mg 12 hours before
Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter
干预措施: Enoxaparin 40 mg 2 hours before arm (Drug)
Enoxaparin 40 mg 12 hours before
Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter
干预措施: Enoxaparin 40 mg 12 hours before arm (Drug)
结局指标
主要结局
Venous thrombosis and/or pulmonary embolism (PE)
时间窗: Postoperative 4 weeks
To assess the venous thrombosis by compression ultrasonography and PE in suspected patients
次要结局
- hospital stay(4 WEEKS)
- Bleeding from the surgery site , drain if any, GIT bleeding,(postoperative 4 weeks)
研究者
MOHAMED ABDELLATIF
phd
Mansoura University