Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Complicated appendicitis
研究概览
简要总结
This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.
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
- •Acute appendicitis where surgery is planned. Diagnosis of appendicitis should be verified either by clinical diagnosis with Adult Appendicitis Score >=16 or by diagnostic imaging (CT-scan, MRI or ultrasound) showing appendicitis. All patients with symptoms at least 3 days should undergo diagnostic imaging before inclusion.
排除标准
- •Complicated appendicitis according to diagnostic imaging. The following findings indicate complicated appendicitis: extraluminal air or extraluminal fecalith; fluid collection, abscess or phlegmon next to appendix; non-enhancement appendiceal wall on contrast enhanced CT-scan.
- •Plasma C-reactive protein >=100
- •Fever measured on emergency department over 38.5 degrees Celcius.
- •Clinical generalized peritonitis or other reason that indicate immediate surgery
- •Pregnancy, pregnancy test is taken from all fertile aged women before randomization
- •Allergy to study antibiotics, or anaphylactic reaction after betalactam antibiotic or other contraindication for metronidazole or ongoing antibiotic treatment or patient is carrier of resistant bacteria. (This exclusion criteria are applicable only on randomization into antibiotic treatment arms)
- •Missing written informed consent
研究组 & 干预措施
Surgery within 8 hours, no antibiotics
Patients are planned for urgent operation, that should be done within 8 hours. Operation can be done during the night time. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.
干预措施: No antibiotics (Drug)
Surgery within 8 hours, no antibiotics
Patients are planned for urgent operation, that should be done within 8 hours. Operation can be done during the night time. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.
干预措施: urgent schedule (Other)
Surgery within 24 hours, no antibiotics
Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.
干预措施: No antibiotics (Drug)
Surgery within 24 hours, no antibiotics
Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.
干预措施: less urgent schedule (Other)
Surgery within 8 hours, antibiotics
Patients are planned for urgent operation, that should be done within 8 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.
干预措施: Antibiotics, cefuroxime and metronidazole (Drug)
Surgery within 8 hours, antibiotics
Patients are planned for urgent operation, that should be done within 8 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.
干预措施: urgent schedule (Other)
Surgery within 24 hours, antibiotics
Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.
干预措施: Antibiotics, cefuroxime and metronidazole (Drug)
Surgery within 24 hours, antibiotics
Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.
干预措施: less urgent schedule (Other)
结局指标
主要结局
Complicated appendicitis
时间窗: during surgery
Surgical finding is complicated appendicitis (AAST Grade III-V)
次要结局
- Postoperative complications(30 days from surgery)
- Gangrenous or perforated appendicitis according to pathological examination.(3 week after surgery)
- Sunshine Appendicitis Grading System Score classification(during surgery)
- Conversions of laparoscopic surgeries to open surgery(during the the first operation for acute appendicitis)
- Time of hospital stay(30 days from surgery)
- Pain measured by numeric rating scale while waiting surgery(up to 36 hours)
- Surgical site infections (SSI) and positive blood cultures(within 30 days from randomization)
研究者
Panu Mentula
Adjunct Professor
Helsinki University Central Hospital