Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) -A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Infectious/Antibiotic Complications
研究概览
简要总结
The purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis
详细描述
This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Age ≥ 18 years
- •Planned appendectomy (laparoscopic or open)
- •Working telephone number or reliable method to contact patient after hospital discharge
排除标准
- •Unable to consent
- •Pregnant Women
- •Prisoners
- •Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS
- •Heart failure
- •Allergy to bupivacaine
- •Unlikely to comply with treatment or follow-up
- •Inpatient consultation for appendicitis
- •Clinically suspected of sepsis based on Sepsis-3 definition
- •Current use of antibiotics for other indications
- •Type 1 Diabetes or uncontrolled hyperglycemia
- •Surgeon preference
- •Patient preference
- •Research team unavailable
研究组 & 干预措施
Restricted Post-Operative Antibiotics Group
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.
Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
干预措施: Multiple standard of care antibiotics for appendicitis, at physicians' discretion (Drug)
Liberal Post-Operative Antibiotics Group
Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics
Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.
干预措施: Multiple standard of care antibiotics for appendicitis, at physicians' discretion (Drug)
结局指标
主要结局
Incidence of Infectious/Antibiotic Complications
时间窗: Up to 30 days after appendicitis surgery
Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.
Number of participant deaths
时间窗: Up to 30 days after appendicitis surgery
Up to 30 days after appendicitis surgery
次要结局
未报告次要终点