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
研究组 & 干预措施
Surgery
Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.
干预措施: Operative management (Procedure)
Non-operative management
If a patient chooses non-operative management and if an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.
干预措施: Drainage or antibiotics (Other)
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
- Need for additional intervention for appendicitis(Within one year of the index admission.)
- Failed attempted procedure.(Within 60 days of randomization.)
- Gastrointestinal (GI) quality of life(30 days after randomization.)
- 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.)
- Complications(Within 60 days of randomization.)
- Occurrence of delayed appendectomy(Within one year of index admission.)
- Need for bowel resection(Within 60 days of randomization.)
- Presence of malignancy in any resected specimen(Within one year of index admission.)
- GI quality of life(60 days after randomization.)