NCT06607887招募中4 期
The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy
Minia University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
Comparison between postoperative parenteral prophylactic antibiotics, and oral antibiotics regarding the incidence of post laparoscopic cholecystectomy infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Adult patients (aged above 18 years) undergoing laparoscopic cholecystectomy.
排除标准
- •patients with comorbidities (Diabetes, malignancies, Immunosuppressed). Lost of follow-up. Patients received antibiotics within 72 hr before admission. Complicated cases involved, gangrenous and perforated cholecystitis and abscess.
研究组 & 干预措施
IV antibiotic
Experimental
干预措施: IV antibiotic (Drug)
Oral Antibiotic
Active Comparator
干预措施: Oral antibiotic (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 4 weeks
DSSI = deep surgical site infection; SSSI = superficial surgical site infection.
次要结局
- Fever(4 weeks)
- Length of the hospital stay(4 weeks)
- Hematoma and Seroma formation(4 weeks)
研究者
Asmaa A. Elsayed
Lecturer of clinical pharmacy
Sohag University
研究点 (1)
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