• Willemieke G van Braak, Jeroen E H Ponten, Charlotte S Loozen, SchotsJudith P MJPMDepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands., van GelovenAnna A WAAWDepartment of Surgery, Tergooi Hospital, Hilversum, the Netherlands., Sandra C Donkervoort, NieuwenhuijzenGrard A PGAP0000-0002-5837-5513Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands., Marc G Besselink, van HeekTjarda N TTNTDepartment of Surgery, Gelderse Vallei Hospital, Ede, the Netherlands., Philip R de Reuver, Bart Vlaminckx, Johannes C Kelder, KnibbeCatherijne A JCAJ0000-0001-9893-4415Department of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, the Netherlands., Hjalmar C van Santvoort, and Djamila Boerma.
• Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.
• Br J Surg. 2022 Feb 24; 109 (3): 267-273.

BackgroundGuidelines 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.MethodsThis 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.ResultsSixteen 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.ConclusionOmitting antibiotic prophylaxis is not recommended.© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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