2024-515958-24-00招募中3 期
Preoperative Antibiotics for Mild or Moderate Acute Cholecystitis (POMMAC): A Non-inferiority, Open-label, Randomized Controlled Trial – Study Protocol
HUS-Yhtymae1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2025年4月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- The rate of postoperative infectious complications within 30 days from randomisation
研究概览
简要总结
To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the rate of postoperative infectious complications in patients undergoing cholecystectomy for acute cholecystitis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed mild or moderate acute cholecystitis (according to Tokyo Guidelines)
排除标准
- •Age under 18 years
- •Class D drug-drug interactions
- •Tokyo Guidelines Grade III cholecystitis (see protocol)
- •subjects with reduced capacity for self-determination
- •Peritonitis
- •Suspicion of cholangitis (Charcot's triad or radiologic findings)
- •Bile duct stones
- •Allergy to all antibiotics in protocol
- •Antibiotics 24 hours prior to randomisation
- •Breastfeeding women
结局指标
主要结局
The rate of postoperative infectious complications within 30 days from randomisation
The rate of postoperative infectious complications within 30 days from randomisation
次要结局
- The conversion rate from laparoscopic to open cholecystectomy during the primary operation
- The Comprehensive Complication Index according to the Clavien-Dindo Classification within 30 days postoperatively
- A composite outcome incorporating the rate of all antibiotic-related adverse outcomes (hypersensitivity reactions, clostridium difficile diarrhea, yeast infections) within 30 days postoperatively
- The length of stay
研究者
Panu Mentula
Scientific
HUS-Yhtymae
研究点 (1)
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