NCT02777307Unknown不适用
Efficacy of Hemopatch in Reducing of Postoperative Bleeding After Laparoscopic Cholecystectomy: Prosective and Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- significant reduction in postoperative hospital stay
研究概览
简要总结
Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing of postperative fluid collection after laparoscopic cholecistectomy, morbidity and postoperative hospital stay.
详细描述
Prospective Multicenter Longitudinal and cohort. The sample size of 150 patients was calculated in order to obtain a statistical power adequacy or higher (Type I error - Alpha = 0.05, Type II Error - Beta = 0:20), assuming the 1-day to reduce the postoperative stay with use Hemopatch compared to the control (average stay little 3 +/- 2 days).
Primary endpoint:
- significant reduction in postoperative hospital stay
Secondary endpoints:
- reduction of subhepatic blood liquid volume
- reduction of liver hematoma
- reduction of postooperative complications as deep surgical site
- reduction rates of reoperation
- reduction in readmission rates
- postoperative pain on the VAS scale 1-10.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gallbladder stone
- •Polyp/neoplasm of gallbladder
排除标准
- •Coagulopathies,
- •Medication with antiplatelet agents
- •Acute cholecystitis
- •Main biliaru duct stone
- •Acute pancreatitis
结局指标
主要结局
significant reduction in postoperative hospital stay
时间窗: 1 year
次要结局
- reducing of subhepatic volume drainage(1 year)
- reducing of liver hematoma(1 year)
- reducing of postoperative complications(1 year)
- reducing of rates of reoperation(1 year)
- reducing of re-hospitalization(1 year)
- To assess postoperative pain by the VAS scale 1-10.(1 year)
研究者
A. Liverani
Head of surgery department
Ospedale Regina Apostolorum
研究点 (2)
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