The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
研究概览
简要总结
Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.
A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of all ages.
- •Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
- •Formal consent for the present study must be signed by the patient or his/her parents
- •Patients with initial presentation of a phlegmon (abscess in evolution)
排除标准
- •Patients with non-perforated appendicitis
- •Presentation with initially non-perforated appendicitis but found perforation at surgery
- •Patient with septic shock
- •Patients who had previous appendectomy
- •Current treatment of malignancy
- •Immunocompromised patients
- •Positive pregnancy test
- •No consent for the study
结局指标
主要结局
Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
时间窗: 12 months
Determine rate and severity of complications after interval appendectomy
时间窗: 12 months
次要结局
- Determine the rate of complete response after percutaneous drainage and antibiotic therapy(12 months)
- Determine the mean surgical value (quality/cost) for each group(12 months)
研究者
Juan Sanabria
Professor of Surgery
Marshall University