Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Number of Participants With a Postoperative Intra-abdominal Abscess
研究概览
简要总结
After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.
详细描述
The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.
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
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Postoperative Perforated Appendicitis (documented by intraoperative photo)
- •Postoperative Laparoscopic Appendectomy
排除标准
- •Nonperforated Gangrenous Appendicitis
- •Nonperforated Purulent Appendicitis
- •Open Appendectomy
研究组 & 干预措施
1-drug Therapy
piperacillin-tazobactam
干预措施: Piperacillin, Tazobactam Drug Combination (Drug)
结局指标
主要结局
Number of Participants With a Postoperative Intra-abdominal Abscess
时间窗: 30 days
Intra-abdominal abscess documented by ultrasound or computerized tomography
次要结局
- Number of Participants With Postoperative Surgical Site Infection(30 days)
- Number of Participants With a Postoperative Readmission(30 days)
