NCT03435900已完成2 期
Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Conventional Antibiotics for Perforated Appendicitis - a Pivotal Quasi-randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Total length of hospital stay
研究概览
简要总结
The objective of this trial is to evaluate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) followed by oral antibiotic for three days is as effective as the current intravenous antibiotic treatment given during and three days after appendectomy for perforated appendicitis. The primary outcome is the total length of hospital stay, defined as the number of hours in hospital after end of operation and until 30-day follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥18 years
- •Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual laparoscopic appendectomy
- •Perforated appendicitis (diagnosed during surgery by the surgeon)
- •Negative p-HCG (women)
- •Written informed consent after written and verbal information (preoperatively for the intervention group and postoperatively for the control group)
排除标准
- •Cannot understand, read or speak Danish
- •Previous allergic reaction to fosfomycin, metronidazole, rhGM-CSF, or penicillins e.g. piperacillin or amoxicillin
- •Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy or appendicitis without perforation
- •Other intra-abdominal pathology requiring surgical intervention at the same operation
- •Known renal or hepatic disease or biochemical evidence at the time of admission
- •Known hematologic disease in current medical treatment
- •American Society of Anesthesiologists (ASA) physical status ≥4 (a patient with severe systemic disease that is a constant threat to life)
- •Body weight >110 kg
- •Surgery converted to open appendectomy
- •Anticipated compliance problems
研究组 & 干预措施
Intervention group
Experimental
干预措施: Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o. (Drug)
Control group
Active Comparator
干预措施: Standard antibiotics intravenously (Drug)
结局指标
主要结局
Total length of hospital stay
时间窗: From end of surgery until 30-days follow-up
in hours
次要结局
- Gastrointestinal Quality of Life Index (GIQLI)(10 days (±2 days) and 30 days (±3 days) postoperatively)
- Postoperative complications(From end of surgery until 30-days follow-up)
- Intraabdominal abscesses requiring drainage(From end of surgery until 30-days follow-up)
- Costs(From end of surgery until 30-days follow-up)
- Surgical site infections requiring surgical drainage(From end of surgery until 30-days follow-up)
- Time to return to normal activities(From end of surgery until 30-days follow-up)
- Side effects(Within 24 hours after surgery and 10 days (±2 days) postoperatively)
- Readmissions(From end of surgery until 30-days follow-up)
- Reoperations(From end of surgery until 30-days follow-up)
- Period of sick leave "absence from work"(From end of surgery until 30-days follow-up)
- Adverse events(From end of surgery until 30-days follow-up)
- Microbiological flora and susceptibility(From end of surgery until 30-days follow-up)
研究者
研究点 (2)
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