Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
研究概览
简要总结
Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •first episode of appendicitis
- •Pain < 48 hours
- •White blood cell count < 18,000
- •temperature < 103º F
- •radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
- •appendiceal diameter < 11 mm
- •ability to take oral antibiotics
排除标准
- •Prior antibiotic treatment for appendicitis
- •presence of medical condition prohibiting surgical therapy
- •radiographic or clinical evidence of abscess or perforation
- •appendiceal mass, positive pregnancy test
- •other diagnosis equally as likely as appendicitis
- •pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
- •inability to take oral antibiotics.
研究组 & 干预措施
Medical Therapy
Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.
干预措施: Piperacillin/Tazobactam (Drug)
Surgical Intervention
Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.
干预措施: Piperacillin/Tazobactam (Drug)
Surgical Intervention
Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.
干预措施: Surgical Treatment (Procedure)
结局指标
主要结局
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
时间窗: 1 Year
Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of health-related quality of life (HRQOL) in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. PedsQL consists of 23 items scored on a 5-point Likert scale (0=never to 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, and 4=0). The total score range is 0-100; the higher the score, the better the HRQOL.
次要结局
- Incidence of Long-term Complications in Medical Therapy Group(1 Year)
- Readmission Rates(1 Year)