Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Number of hospital days
研究概览
简要总结
The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
详细描述
Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.
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
- •1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
排除标准
- •Antibiotic therapy greater than 24 hours prior to considering for enrollment.
- •Attempted drainage before randomization
- •Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
- •Previous major intra-abdominal surgery by laparotomy
- •Hospitalization within 2 weeks of randomization
- •Presence of septic shock on admission.
- •Mechanical ventilation
- •Acute renal failure requiring dialysis
结局指标
主要结局
Number of hospital days
时间窗: Within 60 days of randomization.
This includes all hospital days during the initial stay and any readmission.
次要结局
- Intra-abdominal abscess(More than 7 days after index admission but within 60 days of randomization.)
- Number of interventions for abscess(Within 60 days of randomization.)
- Need for bowel resection.(Within 60 days of randomization.)
- Recurrence(Within one year of index admission.)
- Days of disability(Within 60 days of randomization.)
- GI quality of life(One year after randomization.)
- Need for additional intervention for appendicitis(Within one year of the index admission.)
- Failed attempted procedure.(Within 60 days of randomization.)
- Complications(Within 60 days of randomization.)
- Occurrence of delayed appendectomy(Within one year of index admission.)
- Presence of malignancy in any resected specimen(Within one year of index admission.)
- Need for bowel resection(Within 60 days of randomization.)
- Gastrointestinal (GI) quality of life(30 days after randomization.)