Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

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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.

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Most cited references 24

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Gallstones.

Frank Lammert, Kurinchi S. Gurusamy, Cynthia W. Ko … (2016)

Gallstones grow inside the gallbladder or biliary tract. These stones can be asymptomatic or symptomatic; only gallstones with symptoms or complications are defined as gallstone disease. Based on their composition, gallstones are classified into cholesterol gallstones, which represent the predominant entity, and bilirubin ('pigment') stones. Black pigment stones can be caused by chronic haemolysis; brown pigment stones typically develop in obstructed and infected bile ducts. For treatment, localization of the gallstones in the biliary tract is more relevant than composition. Overall, up to 20% of adults develop gallstones and >20% of those develop symptoms or complications. Risk factors for gallstones are female sex, age, pregnancy, physical inactivity, obesity and overnutrition. Factors involved in metabolic syndrome increase the risk of developing gallstones and form the basis of primary prevention by lifestyle changes. Common mutations in the hepatic cholesterol transporter ABCG8 confer most of the genetic risk of developing gallstones, which accounts for ∼25% of the total risk. Diagnosis is mainly based on clinical symptoms, abdominal ultrasonography and liver biochemistry tests. Symptoms often precede the onset of the three common and potentially life-threatening complications of gallstones (acute cholecystitis, acute cholangitis and biliary pancreatitis). Although our knowledge on the genetics and pathophysiology of gallstones has expanded recently, current treatment algorithms remain predominantly invasive and are based on surgery. Hence, our future efforts should focus on novel preventive strategies to overcome the onset of gallstones in at-risk patients in particular, but also in the population in general.

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Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304).

M Menges, Julian-Camill Harnoss, T. Golling … (2013)

Acute cholecystitis is a common disease, and laparoscopic surgery is the standard of care. Optimal timing of surgery for acute cholecystitis remains controversial: either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics. The ACDC ("Acute Cholecystitis-early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy") study is a randomized, prospective, open-label, parallel group trial. Patients were randomly assigned to receive immediate surgery within 24 hours of hospital admission (group ILC) or initial antibiotic treatment, followed by delayed laparoscopic cholecystectomy at days 7 to 45 (group DLC). For infection, all patients were treated with moxifloxacin for at least 48 hours. Primary endpoint was occurrence of predefined relevant morbidity within 75 days. Secondary endpoints were as follows: (1) 75-day morbidity using a scoring system; (2) conversion rate; (3) change of antibiotic therapy; (4) mortality; (5) costs; and (6) length of hospital stay. Morbidity rate was significantly lower in group ILC (304 patients) than in group DLC (314 patients): 11.8% versus 34.4%. Conversion rate to open surgery and mortality did not differ significantly between groups. Mean length of hospital stay (5.4 days vs 10.0 days; P < 0.001) and total hospital costs (€2919 vs €4262; P < 0.001) were significantly lower in group ILC. In this large, randomized trial, laparoscopic cholecystectomy within 24 hours of hospital admission was shown to be superior to the conservative approach concerning morbidity and costs. Therefore, we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients. (NCT00447304).

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Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis.

Harumi Gomi, Joseph S. Solomkin, David Schlossberg … (2018)

Antimicrobial therapy is a mainstay of the management for patients with acute cholangitis and/or cholecystitis. The Tokyo Guidelines 2018 (TG18) provides recommendations for the appropriate use of antimicrobials for community-acquired and healthcare-associated infections. The listed agents are for empirical therapy provided before the infecting isolates are identified. Antimicrobial agents are listed by class-definitions and TG18 severity grade I, II, and III subcategorized by clinical settings. In the era of emerging and increasing antimicrobial resistance, monitoring and updating local antibiograms is underscored. Prudent antimicrobial usage and early de-escalation or termination of antimicrobial therapy are now important parts of decision-making. What is new in TG18 is that the duration of antimicrobial therapy for both acute cholangitis and cholecystitis is systematically reviewed. Prophylactic antimicrobial usage for elective endoscopic retrograde cholangiopancreatography is no longer recommended and the section was deleted in TG18. Free full articles and mobile app of TG18 are available at: http://www.jshbps.jp/modules/en/index.php?content_id=47. Related clinical questions and references are also included.

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Author and article information

Contributors

Gabriel Sandblom:

ORCID: https://orcid.org/0000-0002-7416-4951

gabriel.sandblom@ki.se

Journal

Journal ID (nlm-ta): Langenbecks Arch Surg

Journal ID (iso-abbrev): Langenbecks Arch Surg

Title: Langenbeck's Archives of Surgery

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 1435-2443

ISSN (Electronic): 1435-2451

Publication date (Electronic): 29 August 2020

Publication date PMC-release: 29 August 2020

Publication date (Print): 2020

Volume: 405

Issue: 8

Pages: 1201-1207

Affiliations

[1 ]GRID grid.24381.3c, ISNI 0000 0000 9241 5705, 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 ]GRID grid.4714.6, ISNI 0000 0004 1937 0626, Department of Surgery, , CLINTEC, Karolinska Institute, ; Stockholm, Sweden

[4 ]GRID grid.7143.1, ISNI 0000 0004 0512 5013, Department of Surgery, , Odense University Hospital, ; J.B. Winsloews Vej 4, 5000 Odense, Denmark

Author information

Gona Jaafar https://orcid.org/0000-0002-8356-2206

Gabriel Sandblom https://orcid.org/0000-0002-7416-4951

Folke Hammarqvist https://orcid.org/0000-0001-9175-4534

Article

Publisher ID: 1977

DOI: 10.1007/s00423-020-01977-x

PMC ID: 7686002

PubMed ID: 32860109

SO-VID: 8a5cb9cd-2cd0-4365-9ec8-cafb0adcc8ac

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 8 July 2020

Date accepted : 23 August 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004359, Vetenskapsrådet;

Award ID: 2018-06926

Award Recipient : Gona Jaafar

Custom metadata

ScienceOpen disciplines: Surgery

Keywords: acute cholecystitis,laparoscopic cholecystectomy,antibiotic prophylaxis,postoperative complication,postoperative infectious complication,bacteriobilia

Data availability:

ScienceOpen disciplines: Surgery

Keywords: acute cholecystitis, laparoscopic cholecystectomy, antibiotic prophylaxis, postoperative complication, postoperative infectious complication, bacteriobilia

Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

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Abstract

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Trial registration

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SICOT-J (Orthopedic surgery and traumatology)

Most cited references 24

Gallstones.

Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304).

Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis.

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