title: Randomized clinical trial of extended versus single-dose perioperative antibiotic prophylaxis for acute calculous cholecystitis.
abstract: BACKGROUND
  Many patients who have surgery for acute cholecystitis receive postoperative antibiotic prophylaxis, with the intent to reduce infectious complications. There is, however, no evidence that extending antibiotics beyond a single perioperative dose is advantageous. This study aimed to determine the effect of extended antibiotic prophylaxis on infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy.
  
  
  METHODS
  For this randomized controlled non-inferiority trial, adult patients with mild acute calculous cholecystitis undergoing cholecystectomy at six major teaching hospitals in the Netherlands, between April 2012 and September 2014, were assessed for eligibility. Patients were randomized to either a single preoperative dose of cefazolin (2000 mg), or antibiotic prophylaxis for 3 days after surgery (intravenous cefuroxime 750 mg plus metronidazole 500 mg, three times daily), in addition to the single dose. The primary endpoint was rate of infectious complications within 30 days after operation.
  
  
  RESULTS
  In the intention-to-treat analysis, three of 77 patients (4 per cent) in the extended antibiotic group and three of 73 (4 per cent) in the standard prophylaxis group developed postoperative infectious complications (absolute difference 0·2 (95 per cent c.i. -8·2 to 8·9) per cent). Based on a margin of 5 per cent, non-inferiority of standard prophylaxis compared with extended prophylaxis was not proven. Median length of hospital stay was 3 days in the extended antibiotic group and 1 day in the standard prophylaxis group.
  
  
  CONCLUSIONS
  Standard single-dose antibiotic prophylaxis did not lead to an increase in postoperative infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy. Registration number: NTR3089 (www.trialregister.nl).
authors.affiliation: Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: C S
authors.initials: CS
authors.lastname: Loozen
authors.affiliation: Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: K
authors.initials: K
authors.lastname: Kortram
authors.affiliation: Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: V N N
authors.initials: VN
authors.lastname: Kornmann
authors.affiliation: Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: van Ramshorst
authors.affiliation: Department of Medical Microbiology, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Vlaminckx
authors.affiliation: Department of Clinical Pharmacology, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: C A J
authors.initials: CA
authors.lastname: Knibbe
authors.affiliation: Department of Clinical Epidemiology, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: J C
authors.initials: JC
authors.lastname: Kelder
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: S C
authors.initials: SC
authors.lastname: Donkervoort
authors.affiliation: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors.forename: G A P
authors.initials: GA
authors.lastname: Nieuwenhuijzen
authors.affiliation: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors.forename: J E H
authors.initials: JE
authors.lastname: Ponten
authors.affiliation: Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands.
authors.forename: A A W
authors.initials: AA
authors.lastname: van Geloven
authors.affiliation: Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: van Duijvendijk
authors.affiliation: Department of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: W J W
authors.initials: WJ
authors.lastname: Bos
authors.affiliation: Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: M G H
authors.initials: MG
authors.lastname: Besselink
authors.affiliation: Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: D J
authors.initials: DJ
authors.lastname: Gouma
authors.affiliation: Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: H C
authors.initials: HC
authors.lastname: van Santvoort
authors.affiliation: Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Boerma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D002437:Cefazolin / Q000008:administration & dosage; D002444:Cefuroxime / Q000008:administration & dosage; D002763:Cholecystectomy; D041881:Cholecystitis, Acute / Q000601:surgery*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011182:Postoperative Care; D011183:Postoperative Complications / Q000453:epidemiology; D011300:Preoperative Care; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D008795:Metronidazole; D002437:Cefazolin; D002444:Cefuroxime