NCT01413659Unknown1 期
Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 150
- 主要终点
- Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.
研究概览
简要总结
The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •More than 14 years old
- •Candidate for elective colorectal surgery
排除标准
- •Denied written informed consent,
- •Severe neutropenia, and
- •Critically ill condition
- •Not meeting inclusion criteria
研究组 & 干预措施
Symbiotic
Experimental
Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host
干预措施: Symbiotic (Biological)
结局指标
主要结局
Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.
时间窗: 15 months
次要结局
- The incidence of postoperative infection including surgical site infections (SSIs) and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning.(15 months)
研究者
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Unknown
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招募中
Unknown
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