Necessity and Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Multicenter, Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Number of Participants with Infectious Postoperative Complications
研究概览
简要总结
This clinical trial is an exploratory clinical trial that evaluates the necessity and effectiveness of empirical antibiotic use in mild and moderate acute inflammatory gallbladder diseases that require surgery, and the incidence of postoperative infection-related complications is compared.
详细描述
Cholecystectomy is the standard treatment for acute cholecystitis, accompanied by pain and fever due to acute inflammation in cholelithiasis patients. Empirical antibiotics are generally used to treat inflammation and prevent exacerbation before and after surgery. According to a previous study that confirmed the use of empirical antibiotics (JAMA. 2014;312(2):145-154. doi:10.1001/jama.2014.7586), the incidence of infectious complications was 15% in the group that used empirical antibiotics, and 15% of those who did not use empirical antibiotics The incidence of infectious complications in the group was 17%, confirming that there was no significant difference between the two groups. Based on these results, it was confirmed that the use of antibiotics after surgery was not clinically effective in reducing postoperative complications of infection.
However, there is a lack of objective research and evidence on the efficacy of empirical antibiotic use, and the use of antibiotics that have not been proven in practice may lead to the extension of hospital stay, waste of medical resources, and an increase in medical expenses. In addition, it can cause the occurrence of multidrug-resistant bacteria, which has been revived due to many problems recently, so caution is required in its use.
If the same anti-inflammatory effect and postoperative results can be obtained only through surgical treatment in mild and moderate acute inflammatory gallbladder disease, it is expected that the indiscriminate use of antibiotics will be reduced, and side effects thereof will be prevented. Therefore, this study intends to determine the effective and rational use of antibiotics through randomized clinical trials according to empirical antibiotics in laparoscopic surgery for patients with acute cholecystitis without evidence of systemic infection. In addition, a multicenter, double-blind, prospective, randomized, placebo-controlled clinical trial according to the use of empirical antibiotics has not been conducted in Korea so far, and thus clinical usefulness is expected to be great.
study population
- Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
- •cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
- •Gallbladder with surrounding organs due to gallbladder inflammation
- •Patients over 19 years of age, under 70 years of age
排除标准
- •patients with elective gallbladder surgery (chronic cholecystitis)
- •gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- •pregnant women, patients under 18 years of age, over 70 years of age
- •patients with simultaneous surgery due to other organ diseases
- •immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
- •patients with hemorrhagic tendency, or with hematologic diseases
- •Patients who underwent percutaneous cholecystectomy (PTGBD)
结局指标
主要结局
Number of Participants with Infectious Postoperative Complications
时间窗: 30 days
Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with the first-generation cephalosporin and normal saline.
次要结局
- Duration of hospitalization(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
研究者
Taeho Hong
Professor
Seoul St. Mary's Hospital