NCT01970683终止3 期
Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- 30-day postsurgical outcome including death, infection, readmission
研究概览
简要总结
The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.
详细描述
Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All elective major GI surgical patients
排除标准
- •• Current episode of acute pancreatitis as defined by clinician
- •Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.
结局指标
主要结局
30-day postsurgical outcome including death, infection, readmission
时间窗: within 30 days after surgery
次要结局
未报告次要终点
研究者
Jan Franko
Surgical Oncologist
Catholic Health Initiatives
研究点 (2)
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