C S Loozen1, K Kortram1, V N N Kornmann1, B van Ramshorst1, B Vlaminckx2, C A J Knibbe3, J C Kelder4, S C Donkervoort5, G A P Nieuwenhuijzen6, J E H Ponten6, A A W van Geloven7, P van Duijvendijk8, W J W Bos9, M G H Besselink10, D J Gouma10, H C van Santvoort1, D Boerma1. 1. Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands. 2. Department of Medical Microbiology, St Antonius Hospital, Nieuwegein, The Netherlands. 3. Department of Clinical Pharmacology, St Antonius Hospital, Nieuwegein, The Netherlands. 4. Department of Clinical Epidemiology, St Antonius Hospital, Nieuwegein, The Netherlands. 5. Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 6. Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands. 7. Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands. 8. Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands. 9. Department of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands. 10. Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Abstract
BACKGROUND:Many patients who have surgery for acute cholecystitis receivepostoperative 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. CONCLUSION: 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).
RCT Entities:
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. CONCLUSION: 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: Davide La Regina; Matteo Di Giuseppe; Stefano Cafarotti; Andrea Saporito; Marcello Ceppi; Francesco Mongelli; Florian Bihl; Ruben Carlo Balzarotti Canger; Antonjacopo Ferrario di Tor Vajana Journal: Surg Endosc Date: 2018-10-16 Impact factor: 4.584
Authors: Anne Loes van den Boom; Elisabeth M L de Wijkerslooth; Joost van Rosmalen; Frédérique H Beverdam; Evert-Jan G Boerma; Marja A Boermeester; Joanna W A M Bosmans; Thijs A Burghgraef; Esther C J Consten; Imro Dawson; Jan Willem T Dekker; Marloes Emous; Anna A W van Geloven; Peter M N Y H Go; Luc A Heijnen; Sander A Huisman; Dayanara Jean Pierre; Joske de Jonge; Jurian H Kloeze; Marc A Koopmanschap; Hester R Langeveld; Misha D P Luyer; Damian C Melles; Johan W Mouton; Augustinus P T van der Ploeg; Floris B Poelmann; Jeroen E H Ponten; Charles C van Rossem; Wilhelmina H Schreurs; Joël Shapiro; Pascal Steenvoorde; Boudewijn R Toorenvliet; Joost Verhelst; Hendt P Versteegh; Rene M H Wijnen; Bas P L Wijnhoven Journal: Trials Date: 2018-05-02 Impact factor: 2.279