Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial
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CONTROLLED CLINICAL TRIALS
Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial Gona Jaafar 1
&
Gabriel Sandblom 2
&
Lars Lundell 3,4 & Folke Hammarqvist 1
Received: 8 July 2020 / Accepted: 23 August 2020 # The Author(s) 2020
Abstract Purpose Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts. Methods The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed. Results A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups. Conclusion PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia. Trial registration The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015. Keywords Acute cholecystitis . Laparoscopic cholecystectomy . Antibiotic prophylaxis . Postoperative complication . Postoperative infectious complication . Bacteriobilia
Introduction The standard treatment for mild to moderate acute cholecystitis is early laparoscopic cholecystectomy [1–4]. Given that the overall complication rate after cholecystectomy is approximately 11% (Swedish GallRiks register) [5], the risk for
* Gabriel Sandblom [email protected] 1
Subject Trauma Reparative Medicine, CLINTEC, Karolinska University Hospital, 14186 Stockholm, Sweden
2
Department of Clinical Science and Education, Department of Surgery, Södersjukhuset, Karolinska Institute, Stockholm, Sweden
3
Department of Surgery, CLINTEC, Karolinska Institute, Stockholm, Sweden
4
Department of Surgery, Odense University Hospital, J.B. Winsloews Vej 4, 5000 Odense, Denmark
postoperative infectious complications (PIC) after gallstone surgery is small but not negligible. The risk appears to be enhanced by the severity of the ongoing cholecystitis, and PIC has been shown to occur in 17% or more of patients with grades I and II acute cholecystitis [6]. The pathogenesis of PIC in connection with elective and acute operations for gallstone disease i
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