Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- time (days) away from normal activities (or time until returns to normal activities)
研究概览
简要总结
The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.
详细描述
There are two surgical treatment options for children with ruptured appendicitis. Early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. Another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. The rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. Both of these treatment options are currently used by many pediatric surgeons across the United States and both appear to work well. The two treatment have never been compared in any prospective study. The primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. Secondary outcome measures include complication rates, quality of life measures (SF10), hospital cost analysis, and others.
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
- •Clinical diagnosis of ruptured appendicitis
排除标准
- •Inability to have usual follow up care (e.g. transient to area)
研究组 & 干预措施
1
Early appendectomy
干预措施: early appendectomy (Procedure)
2
Interval appendectomy
干预措施: interval appendectomy (Procedure)
结局指标
主要结局
time (days) away from normal activities (or time until returns to normal activities)
时间窗: At completion of study
次要结局
- complication rates of each treatment arm:(At completion of study)
- Wound infection or dehiscence(Throughout study period)
- Intra-abdominal abscess(Throughout study period)
- Requires reoperation(Throughout study period)
- Bowel obstruction(Throughout study period)
- central venous catheter-related infection(Throughout study period)
- interventional radiology-related complication(Throughout study period)
- Total hospital length of stay(At study completion)
- # patients with central venous line(At study completion)
- # with interventional radiology drainage(At study completion)
- # of return visits to pediatrician, ED, surgery office(At study completion)
- Other complication(At study completion)
- quality of life questionnaire (SF10)(At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment)
- hospital costs(At study completion)