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Published on: September 20, 2019
Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial
Willemieke G van Braak1, Jeroen E H Ponten2, Charlotte S Loozen1
1Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.
Insights
Omitting antibiotic prophylaxis in emergency cholecystectomy for cholecystitis is not recommended. A clinical trial found higher surgical site infections when antibiotics were omitted, failing to prove non-inferiority.
Area of Science:
- Surgical Infectious Diseases
- Clinical Trials
- Evidence-Based Medicine
Background:
- Current guidelines for antibiotic prophylaxis in emergency cholecystectomy for cholecystitis rely on low-quality evidence.
- This study aimed to evaluate if omitting antibiotics is non-inferior to prophylactic use.
Purpose of the Study:
- To determine the non-inferiority of omitting antibiotic prophylaxis compared to its use in patients undergoing emergency cholecystectomy for acute calculous cholecystitis.
Main Methods:
- A multicenter, randomized, open-label, non-inferiority trial.
- Adults with acute calculous cholecystitis received either a single dose of cefazolin or no antibiotic prophylaxis.
- Primary endpoint: composite of postoperative infectious complications within 30 days.
Main Results:
- Postoperative infectious complications occurred in 7.1% of the prophylaxis group vs. 12.6% in the no-prophylaxis group.
- Non-inferiority of omitting prophylaxis was not demonstrated (absolute difference 5.5%).
- Surgical-site infections were significantly higher in the no-prophylaxis group (12.1% vs. 5.3%).
Conclusions:
- Omitting antibiotic prophylaxis in this setting is not recommended.
- The study did not prove that omitting antibiotics is as safe as their prophylactic use.
- Increased risk of surgical-site infections necessitates continued antibiotic prophylaxis.
Background:
Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use.
Methods:
This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay.
Results:
Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay.
Conclusion:
Omitting antibiotic prophylaxis is not recommended.
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