Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
详细描述
All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •elective laparoscopic cholecystectomy;
- •patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.
排除标准
- •acute cholecystitis;
- •acute cholangitis;
- •acute pancreatitis;
- •pregnant or lactating women;
- •antibiotic allergy;
- •antibiotic therapy within 48 hours to 7 days prior to surgery;
- •clinically active infection at the moment of surgery;
- •evidence of common bile duct stones;
- •contraindications for laparoscopic cholecystectomy;
- •no other additional procedure;
- •indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc).
- •patients unable to give informed consent.
研究组 & 干预措施
Placebo
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
干预措施: Placebo (Drug)
Ampicillin-sulbactam
Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
干预措施: Ampicillin-sulbactam (Drug)
Ciprofloxacin
Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 30 days after operation
Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.
次要结局
- Extra-abdominal infections(30 days)
- Adverse events.(30 days)
- Quality of life(30 days)
研究者
Erasmo Spaziani
Professor
University of Roma La Sapienza