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Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a
Charlotte S Loozen1, Hjalmar C van Santvoort2, Antoinette A W van Geloven3
1Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands. c.loozen@antoniusziekenhuis.nl.
Insights
Preoperative antibiotic prophylaxis before emergency cholecystectomy for acute cholecystitis is being studied. This trial investigates if skipping antibiotics is as safe as using them to prevent infectious complications.
Area of Science:
- Surgical infectious disease
- Clinical trials methodology
- Evidence-based medicine
Background:
- The necessity of perioperative antibiotic prophylaxis for preventing infectious complications after emergency cholecystectomy for acute cholecystitis remains debated.
- Current evidence-based guidelines are lacking, leading to varied practices among surgeons and hospitals.
- Recent studies indicate postoperative antibiotic prophylaxis does not reduce infectious complications, but the role of preoperative prophylaxis is unstudied.
Purpose of the Study:
- To determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis.
- To assess if the absence of preoperative antibiotic prophylaxis is noninferior to its presence in preventing postoperative infectious complications.
Main Methods:
- The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial.
- Patients with mild or moderate acute cholecystitis receive either a single preoperative dose of antibiotic prophylaxis or no prophylaxis.
- The primary endpoint is a composite of all postoperative infectious complications within 30 days; secondary endpoints include individual complications, hospital stay, and costs.
Main Results:
- This section is not yet available as the trial is ongoing or results have not been published.
- The study hypothesizes that the absence of antibiotic prophylaxis is noninferior to its presence.
- A total of 454 subjects are required, with analysis based on the intention-to-treat principle.
Conclusions:
- The PEANUTS II trial aims to provide evidence-based guidance on the use of antibiotic prophylaxis in this surgical context.
- Findings will inform clinical practice and potentially reduce unnecessary antibiotic use.
- This research addresses a critical gap in understanding preoperative antibiotic prophylaxis for acute cholecystitis.
Background:
The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. Evidence-based guidelines are lacking, and consequently the use of antibiotic prophylaxis varies greatly among surgeons and hospitals. Recently, high-level evidence became available demonstrating that postoperative antibiotic prophylaxis in patients with acute cholecystitis does not reduce the risk of infectious complications. Preoperative antibiotic prophylaxis in relation to the risk of infectious complications, however, has never been studied.
Methods:
The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial whose aim is to determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Patients with mild or moderate acute cholecystitis, as defined according the Tokyo Guidelines, will be randomly assigned to a single preoperative dose of antibiotic prophylaxis (2000 mg of first-generation cephalosporin delivered intravenously) or no antibiotic prophylaxis before emergency cholecystectomy. The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery. Secondary endpoints include all the individual components of the primary endpoint, all other complications, duration of hospital stay, and total costs. The hypothesis is that the absence of antibiotic prophylaxis is noninferior to the presence of antibiotic prophylaxis. A noninferiority margin of 10% is assumed. With a 1-sided risk of 2.5% and a power of 80%, a total of 454 subjects will have to be included. Analysis will be performed according to the intention-to-treat principle.
Discussion:
The PEANUTS II trial will provide evidence-based advice concerning the utility of antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis.
Trial Registration:
Netherlands Trial Register, NTR5802 . Registered on 4 June 2016.
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