Randomized Controlled Trial on Pre-operative Withdrawal Versus no Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of hematoma
研究概览
简要总结
This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery.
详细描述
This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery. Simple randomization will be performed and allocation is via closed envelope method. The surgeon will be blinded regarding the usage of Aspirin. The primary outcome is the incidence of post-operative hematoma formation within the first 24 hours after surgery. The secondary outcomes are the incidence of post-operative seroma formation within 24 hours, the incidence of post-operative hematoma requiring intervention (including blood transfusion, percutaneous drainage and surgical hemostasis) within 30 days, pain at regular intervals and the incidence of other post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair
- •Age 21-80 years
- •Patients taking Aspirin
- •BMI 18-30
排除标准
- •Age <21 and >80years
- •Recurrent inguinal hernia
- •Coagulopathy
- •Patients who can't stop Aspirin
- •BMI <18 and >30
结局指标
主要结局
Incidence of hematoma
时间窗: 24 hours
Postoperative scrotal or groin hematoma (not including skin bruising)
次要结局
- Incidence of seroma(24 hours)
- Incidence of hematoma requiring intervention(30 days)
