A Prospective, Nonrandomized, Study Comparing the Use of Aspirin and Intraoperative Blood Loss and Postoperative Complications Following Open Inguinal Hernia Repair.
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- intraoperative blood loss
研究概览
简要总结
The purpose of this study is to determine whether aspirin taken in the perioperative period will increase the blood loss associated with open inguinal hernia repairs. A secondary purpose of this study is to determine if the aspirin administered in the perioperative period increases the risk of complications associated with open inguinal hernia repairs.
详细描述
This is a prospective, non-randomized, study which compares the use of 81mg of aspirin, 325mg of aspirin or no aspirin in adult men undergoing an open tension free mesh inguinal hernia repair. Subjects currently taking 81mg or 325mg of aspirin will undergo inguinal hernia repair without having their medications stopped. Patient not currently taking aspirin will act as controls. Intraoperative blood loss will be measured utilizing a gravimetric method by weighing surgical sponges before and after use. Subjects will be followed for thirty days postoperatively and be evaluated for bleeding complications. The specific complications include wound or scrotal hematomas, return to the operating room within 72 hour for bleeding, wound infection, early recurrent hernia, excessive wound ecchymosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •adult male veterans ages 18-99
- •inguinal hernia
- •subjects currently taking 81mg, 325mg or no aspirin
排除标准
- •recurrent hernia
- •"giant" hernia
- •International Normalized Ratio > 1.7
- •Hemophilia or other know congenital bleeding disorder
- •Cirrhosis of hepatitis with coagulopathy
- •Thrombocytopenia with platelet counts < 100,000
- •Subjects currently on Coumadin or other platelet inhibitors
研究组 & 干预措施
81mg aspirin
This arm will include perioperative 81 mg of aspirin.
干预措施: Aspirin (Drug)
325mg aspirin
Subjects will be taking 325mg of aspirin.
干预措施: Aspirin (Drug)
结局指标
主要结局
intraoperative blood loss
时间窗: intraoperative only
intraoperative blood loss will be accurately measured among the three arms of the study
次要结局
- Number of Participants with Serious and Non-Serious Adverse Events(30 days post operative)
研究者
Joseph Vitello, MD
Interim Chief of Surgical Services
Jesse Brown VA Medical Center