Prospective Randomized Control Study of Clinical Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 529
- 主要终点
- surgical complication
研究概览
简要总结
529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria.
They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.
详细描述
529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the 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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have diagnosed -cholecystitis with / without GB stone, GB polyp
排除标准
- •Suspected cholangitis and GB cancer
- •CBD stone history
- •Preoperative administration of antibiotics within 7days.
- •Suspected pregnancy
- •Open conversion.
- •Patients refuse this study
研究组 & 干预措施
Antibiotic treatment group
They were Antibiotic treatment group (AG, cefotetan 1g, 1 dose/prophylactic) before surgery.
干预措施: Cefotetan (Drug)
结局指标
主要结局
surgical complication
时间窗: 30days
surgical site infection
次要结局
未报告次要终点