Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 21
- 主要终点
- All complications occurring during hospitalization or within 30 days postoperative. There are 2 main types of postoperative infectious complications: - Surgical site infections (SSI) - Systemic infections - Remote surgical site infections.
研究概览
简要总结
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified.
The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.
The secondary objectives are:
- Rates of infectious complications according to duration of preoperative antibiotic
- Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
- Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections)
- Comparison of germs found in the bile during the postoperative infectious complications
- Duration of hospitalization
- Readmission rate for surgical site infections
- Rate of reoperation for surgical site infection
- Overall mortality rate at 30 days
- Mortality rates specific to 30 days
详细描述
This is a multicentre national, comparative, randomized, uncontrolled, non-inferiority, unblinded (open). Two groups of patients are compared (postoperative antibiotics versus no antibiotics postoperatively) in a ratio (1:1), intention to treat.
The international consensus conference held in Tokyo, has defined precisely the ALC(acute lithiasic cholecystis)and distinguished several stages of severity. For this study, this definition of degrees of severity will be used.
ALC is defined by the association of local signs:
- Murphy's sign
- mass
- pain
- defense of the right upper quadrant
- systemic signs (fever, leukocytosis, elevated C-reactive protein).
When the diagnosis of ALC is clinically suspected, an imaging procedure (ultrasound, a CT or MRI) is needed to confirm the diagnosis.
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
- None
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
- •Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder)
- •Requiring early cholecystectomy (progression of symptoms <5 days
- •In an adult patient (>18 years)
- •For each patient included the consent form must have been read, understood and signed.
排除标准
- •Severe acute cholecystitis (with organ dysfunction)
- •Acalculous cholecystitis
- •Biliary peritonitis
- •Abscess perivesicular
- •Cholangitis
- •Acute Pancreatitis
- •Septic shock
- •Stone of bile duct
- •Physical or mental state does not allow participation in the study
- •Contraindication to surgery
- •Classification ASA (American Society of Anesthesiologists) IV-V or life expectancy <48 hours
- •Suspected pre-or intraoperative cancer of the gallbladder
- •Pregnancy or breastfeeding
- •Treatment course with methotrexate, imidazole
- •Known history of allergy to Augmentin ®
研究组 & 干预措施
Amoxicillin clavulanic acid
Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.
干预措施: Amoxicillin clavulanic acid (Drug)
No medication
no postoperative antibiotics
干预措施: No medication (Other)
结局指标
主要结局
All complications occurring during hospitalization or within 30 days postoperative. There are 2 main types of postoperative infectious complications: - Surgical site infections (SSI) - Systemic infections - Remote surgical site infections.
时间窗: 30 days postoperative
次要结局
- Rates of infectious complications according to duration of preoperative antibiotic(30 days postoperative)
- Influence of surgical drainage after surgery for occurrence of postoperative infectious complications(30 days postoperative)
- Nature of infectious complications analysis (surgical site infections, infections distance)(30 days postoperative)
- Comparison of germs found in bile, the germs found in postoperative infectious complications(since the infectious complication persist)
- Duration of hospitalization(until the release of hospitalization, otherwise at 30 days postoperative)
- Readmission rate for surgical site infections (SSI)(30 days postoperative)
- Rate of reoperation for SSI(30 days postoperative)
- Overall mortality rate(30 days postoperative)
- Specific mortality rates(30 days postoperative)