Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pilot
研究概览
简要总结
The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess.
The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.
详细描述
This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study.
Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study.
Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.
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
- 否
入选标准
- •Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
- •Children of any age will be included.
排除标准
- •Patients with immune deficiency
- •Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
- •Acute sepsis or severe pain from perforation not allowing for delayed management.
研究组 & 干预措施
1
Drainage with interval appendectomy
干预措施: Drainage and Interval Appendectomy (Procedure)
2
appendectomy on presentation
干预措施: Operation on Admission (Procedure)
结局指标
主要结局
Pilot
时间窗: 3 months
次要结局
- PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time(3 months)