Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis. Is it Necessary?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of infectious postoperative complications
研究概览
简要总结
Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20% of symptomatic patients.
Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates forms of diseases and antibiotic therapy in the postoperatory of these patients remains under discussion. However in the beginning, AC presents itself as an steril process, the obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis, as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a significant factor associated with total, as well as infectious, operative complications. Regarding this, for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the best treatment after LC in patients with mild and moderate cholecystitis without intraoperative complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. In the other hand, others do not prescribe antimicrobial treatment after surgery in these selected patients.
There is controversy regarding the postoperative treatment with antibiotics in patients with mild and moderate cholecystitis and all the evidence about this topic.
Therefore, investigators decided to conduct a prospective randomized study in patients undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. The patients will be randomized to receive AMC or placebo after surgery. With this study investigators intend to prove that are no clinical differences in postoperative outcomes between patients treated with AMC and placebo.
The primary aim of the trial is to assess that there are no benefits in the use of postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy was performed.
详细描述
Double blind randomized clinical trial
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years old
- •Patients with diagnose of mild or moderate acute cholecystitis.
- •Underwent laparoscopic cholecystectomy on Italian Hospital of Buenos Aires
排除标准
- •They refuse to participate from the trial or the process of informed consent.
- •Have known allergies or hypersensitivity to Mosapride or lactose (used for placebo).
- •Patients with severe cholecystitis
- •Patients with moderate cholecystitis who presents liver abscess, gallbladder abscess, cholangitis or bile peritonitis.
- •Intraoperative findings like liver cancer, liver metastases, common bile duct stones or gallbladder carcinoma.
- •Patients with conversion to laparotomy
- •Previous treatment with antibiotics for more than five days.
- •Patients with active oncological diseases, AIDS, diabetes, transplanted.
研究组 & 干预措施
Group A (Amoxicillin Clavulanic)
Intake of active drug (Amoxicillin Clavulanic). 3 g per day divided into 3 oral intakes of 1 g each (2 pill of Amoxicillin Clavulanic every 8 hrs). This treatment will begin on postoperative day 1 for 5 days.
干预措施: Amoxicillin clavulanic (Drug)
Placebo
Intake of placebo (Lactose). 1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of infectious postoperative complications
时间窗: 30 days
Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to acute mild and moderate cholecystitis, with antibiotics or placebo
次要结局
- Number of days of hospital stay or readmissions.(30 days)
- Number of surgical reinterventions or reoperations.(30 days)
研究者
MARTIN DE SANTIBAÑES
MD
Hospital Italiano de Buenos Aires