Randomized Clinical Trial to Test the Efficacy and Safety of Outpatient Clinical Management of Urgent Laparoscopic Appendectomy in Complicated Acute Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 主要终点
- length of hospital stay (LHS)
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of outpatient management of complicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.
详细描述
The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in complicated acute appendicitis.
This was a single center randomized controlled clinical trial consisting in 2 treatment groups. Patients were recruited in University Hospital of Tarragona Joan XXIII of Spain.
All patients admitted in the emergency department at University Hospital of Tarragona Joan XXIII with acute appendicitis diagnosis were likely to enter in the study.
All patients who met the inclusion criteria and none of the exclusion criteria were admitted to the study for emergency surgery.
In order to avoid the biases a unique anesthetic and surgical protocol were established for both groups.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years old
- •ASA classification (American Society of Anesthesiologists) less than or equal to 3
- •patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital and an adequate cognitive capacity.
排除标准
- •pregnancy or breastfeeding
- •complicated Acute Appendicitis
- •surgical management performed in more 90 minutes
结局指标
主要结局
length of hospital stay (LHS)
时间窗: up to 5 days
The length of hospital stay (LHS) was calculated from the date and time of urgent appendectomy surgery to the date and time of hospital discharge, based on the hours of hospital stay (assessed up to 5 days)
次要结局
- failures of the outpatient management(assessed up to 30 days)
- readmissions(assessed up to 30 days)
- hospitals cost(through study completion, an average of 1 year)
研究者
Jordi Elvira Lopez
MD PhD
HJ23