Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?; a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Number of Participants With Infectious Postoperative Complications
研究概览
简要总结
During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial.
Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the patients who has no evidence of systemic infection, according to the usage of postoperative antibiotics or not. The investigators expect that the routine use of postoperative antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have no effects on the postoperative morbidity.
详细描述
Primary outcome of this study is the confirmation of safety in the cases of acute cholecystitis without postoperative antibiotics usage after laparoscopic cholecystectomy. For this purpose, the investigators compare the surgical infectious outcomes including the wound infection or abdominal infections according to the usage of postoperative antibiotics after laparoscopic cholecystectomy.
Secondary outcome of this study is the confirmation of efficacy according to skip the use of postoperative antibiotics after laparoscopic cholecystectomy.
The investigators estimate the efficacy using the comparing the outcomes such as duration of hospitalization according to the use of postoperative antibiotics or not.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grade I Tokyo guideline for acute cholecystitis
- •grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation
排除标准
- •chronic cholecystitis
- •gallbladder polyp or gallbladder cancer
- •the patient who underwent reduced port surgery
- •the patient who underwent common bile duct exploration during the operation
- •the patient who underwent concurrent operation
- •the patient who had past history of upper abdominal surgery
- •the patient who had a immunodeficiency state
- •the case which had a suspicion of delayed bile leakage
- •the case which had a incomplete cystic duct ligation
- •the patient who underwent open conversion surgery during the operation
- •the patient who had a high risk of bleeding
研究组 & 干预措施
Group A (cephalosporin)
During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
干预措施: Cephalosporin (Drug)
Group B (placebo)
During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
干预措施: Placebo (Drug)
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 antibiotics or placebo
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