Role of delay and antibiotics on PERForation rate while waiting appendECTomy – Randomized non-inferiority trial (PERFECT) - PERFECT

Helsinki University Hospital0 个研究点目标入组 1,800 人开始时间: 2019年12月13日最近更新: 2021年10月18日

适应症

试验速览

暂无简介。

•Diagnosed acute appendicitis, in which laparoscopic appendectomy is planned. Diagnosis should be confirmed either by high Adult Appendicitis Score (16 or over) or by diagnostic imaging including computed tomography (CT), ultrasound or magnetic resonance imaging (MRI). All patients with symptoms over three days should undergo CT or MRI before inclusion.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1. Complicated appendicitis based on imaging studies. These include following findings:
•a. extraluminal air or extraluminal fecalith
•b. fluid collection, abscess or phlegmon around appendix
•c. nonenhancing appendices wall on contrast enhanced imaging
•2. Likely complicated appendix based on laparatory testing defined by plasma C-reactive protein (P-CRP) 100 mg/l or over.
•3. Fever measured on emergency department over 38.5 degrees Celsius
•4. Clinical diffuse peritonitis or other reason , which may indicate immediate surgery.
•5. Pregnancy
•6. Age below 18 years
•7. Missing written informed consent
•8. Allergy to cefalosporins or metronidazole or anaphylaxis after penicillin-group antibiotics
•9. Ongoing antibiotic treatment
•10. Patient is known carrier of resistant bacterial strain such as ESBL E.Coli

发起方

Helsinki University Hospital