Necessity of Preoperative Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Number of Participants with Infectious Postoperative Complications
研究概览
简要总结
In this study, the investigators compared the surgical outcomes according to the type of antibiotics before surgery in patients who did not have evidence of systemic infection during acute cholecystitis.
The primary purpose of the study was to determine the type of preoperative antibiotics in patients who were scheduled for cholecystectomy, because of the mild (grade I) or moderate (grade 2) acute inflammatory gallbladder disease without gallbladder perforation. The investigators compared the incidence of postoperative complications according to the types of preoperative antibiotics(the first-generation vs second-generation cephalosporin).
The secondary purpose of the study was to confirm the clinical efficacy of first-generation cephalosporins following the use of empirical antibiotics. And the investigators compare with postoperative pain, postoperative hospital stay, re-hospitalization, and need for additional treatment. In addition, the investigators compare the postoperative complications, such as atelectasis and postoperative ileus.
详细描述
A. Background
B. Code name of clinical trial drug or medical device or generic name of main ingredient, raw material drug (raw material in case of medical device) and its quantity, formulation (form / structure / number in case of medical device), etc
- Test drug : normal saline
- control drug : Cefazolin inj., 1 g, Cefazolin sodium, white crystal, vial injection with crystalline powder or lump
C. Target disease Acute cholecystitis without evidence of gallbladder perforation among mild (Grade I) and severe (Grade II) classification of acute cholecystitis according to Tokyo guidelines
D. Subject selection criteria, exclusion criteria, number of target subjects and their rationale
- Inclusion criteria
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
- 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