PERFECT-Antibiotics
Trial question
Is no antibiotic treatment noninferior to preoperative antibiotic treatment in patients awaiting surgery for presumed uncomplicated acute appendicitis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 1774
1774 patients (793 female, 981 male).
Inclusion criteria: adult patients awaiting surgery for presumed uncomplicated acute appendicitis.
Key exclusion criteria: allergies or other contraindications to study antibiotics; previously started antibiotic treatment; pregnancy; suspicion of perforated appendicitis; other reasons to perform prompt surgery.
Interventions
N=886 no antibiotic treatment (no antibiotics administered while awaiting surgery).
N=888 antibiotic treatment (intravenous cefuroxime 1,500 mg and metronidazole 500 mg every 8 hours until surgery).
Primary outcome
Perforated appendicitis diagnosed during surgery
8.9%
8.3%
8.9 %
6.7 %
4.5 %
2.2 %
0.0 %
No antibiotic
treatment
Antibiotic
treatment
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in perforated appendicitis diagnosed during surgery (8.9% vs. 8.3%; AD 0.6%, 95% CI -2 to 3.2).
Secondary outcomes
Significant increase in surgical site infection (3.2% vs. 1.6%; AD 1.6%, 95% CI 0.2 to 3).
Conclusion
In adult patients awaiting surgery for presumed uncomplicated acute appendicitis, no antibiotic treatment was noninferior to antibiotic treatment with respect to perforated appendicitis diagnosed during surgery.
Reference
Karoliina Jalava, Ville Sallinen, Hanna Lampela et al. Role of Preoperative Antibiotic Treatment While Awaiting Appendectomy: The PERFECT-Antibiotics Randomized Clinical Trial. JAMA Surg. 2025 May 14:e251212. Online ahead of print.
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