Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Post procedural leaking at the needle insertion site
研究概览
简要总结
The purpose of this study is to compare two different methods that are used for inserting the needle during paracentesis. One method is called the "coaxial insertion technique" and the other is called the "z-tract technique". Researchers would like to see which method is better and leads to less problems like oozing from the needle insertion site and pain during the procedure. Both methods are approved and currently used methods for doing a paracentesis at the University of Virginia. Which method is used generally depends on physician preference. There have been no studies done to date that compare these two methods for needle insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Agreement to participate
- •Patients with cirrhosis (confirmed by liver biopsy or clinically diagnosed) and ascites
- •Patients presenting to UVA Digestive Health Clinic for a scheduled therapeutic paracentesis who do not have any contraindications to the procedure
- •Ability to be reliably contacted by phone 24 hours following paracentesis
排除标准
- •Prisoners
- •Non-english speaking
- •Paracentesis with less than 5 liters of ascitic fluid removed. (If this occurs, the specific subject encounter will be removed from the study but the subject may be included if at their next regularly scheduled paracentesis 5 liters or greater of ascitic fluid is removed.)
结局指标
主要结局
Post procedural leaking at the needle insertion site
时间窗: 24 hours
次要结局
- Patient reported procedural pain(Immediately following paracentesis)
研究者
Amy Rubin, MD
Department of Gastroenterology
University of Virginia