Prophylactic Antibiotic in Non-complicated Low Risk Laparoscopic Cholecystectomy; Is it Worthy? A Prospective Randomized Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- To compare between infection rate at both groups
研究概览
简要总结
To Compare between outcomes of Antibiotic Prophylaxis and No antibiotic prophylaxis in non-complicated low risk laparoscopic cholecystectomy
详细描述
There is no doubt that Laparoscopic cholecystectomy (LC) is the surgery of choice in cholelithiasis [1].
Routine antibiotic prophylaxis in LC decreases the rate of intra and post operative infections specifically the Surgical site infection (SSI) [2]. However, the rate of antibiotic side effects remains considerable, mainly antibiotic resistance to the commonly used antibiotics as Cefoperazone and other antibiotics used in routine prophylaxis [3]. So Some studies proved that No need for antibiotic prophylaxis [4]. In spite, no antibiotic prophylaxis may lead to infections mainly SSI and prolongation of hospitalization time [5]. However None of these studies has proved Superiority over the other and stills a matter of controversy [6]. For this reason more efforts are directed to limit the use of antibiotic in non complicated low risk laparoscopic cholecystectomy. Prophylaxis in this study is directed to start from time of admission till 1 month post operative. In our study we Follow both outcomes to compare between both techniques
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male and female at the Age of 18 years or above.
- •Symptomatic gall bladder stones.
- •Ultrasonography shows gall bladder stones.
- •Uncomplicated chronic calculous cholecystitis
排除标准
- •Complicated gall bladder stones.
- •Malignant gall bladder mass
- •Laparoscopic cholecystectomy with Common Bile Duct (CBD) exploration.
- •Absolute contraindications to LC like cardiovascular, pulmonary disease, coagulopathies and end stage liver disease.
- •The cases of Laparoscopic Cholecystectomy conversion to Open Cholecystectomy due to equipment failure.
- •Immunocompromised patients as Uncontrolled DM, HIV and patients on certain medications as corticosteroids and chemotherapy.
研究组 & 干预措施
Group 1
Having prophylactic antibiotic in laparoscopic cholecystectomy
干预措施: Augmentin (Drug)
结局指标
主要结局
To compare between infection rate at both groups
时间窗: Baseline
Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
Hospitalization time
时间窗: Baseline
Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
次要结局
- Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitis(Baseline)
研究者
Ahmed Hassan Mohammed Ali
Assiut Lecturer
Assiut University