Abstract
PurposeEvidence 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.MethodsThe 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.ResultsA 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.ConclusionPAP 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 registrationThe study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.
Highlights
The standard treatment for mild to moderate acute cholecystitis is early laparoscopic cholecystectomy [1,2,3,4]
Current guidelines do not support the routine use of preoperative antibiotic prophylaxis (PAP) for elective cholecystectomy for uncomplicated gallstone disease [13,14,15], but surprisingly adherence to international guidelines is generally low in Europe [16, 17]
We did not reach sufficient statistical power to detect a minor reduction in postoperative infectious complication (PIC) rate, the absence of any significant impact speaks against the routine use of PAP
Summary
The standard treatment for mild to moderate acute cholecystitis is early laparoscopic cholecystectomy [1,2,3,4]. Despite the fact that surgery for acute cholecystitis is one of the most frequently performed procedures by general surgeons throughout the world, the use of PAP varies between hospitals and between surgeons, as recently shown in a nationwide study from Sweden [12]. Current guidelines do not support the routine use of PAP for elective cholecystectomy for uncomplicated gallstone disease [13,14,15], but surprisingly adherence to international guidelines is generally low in Europe [16, 17]. In a systemic review and metaanalysis of low-risk patients undergoing elective laparoscopic cholecystectomy, concluded that PAP is safe and effective in reducing surgical site infections, global infections and postoperative length of hospital stay [18]. The effectiveness of PAP in acute cholecystitis needs to be confirmed
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