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Guideline Summary
Guideline Title
Best practice policy statement on urological surgery antimicrobial prophylaxis.
Bibliographic Source(s)
American Urological Association Education and Research, Inc. Best practice policy statement on urologic surgery antimicrobial prophylaxis. Baltimore (MD): American Urological Association Education and Research, Inc.; 2007. 45 p. [100 references]
Guideline Status

This is the current release of the guideline.

The American Urological Association Education and Research, Inc. reaffirmed the currency of the guideline in 2010.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • August 15, 2013 – Fluoroquinolone Antibacterial Drugs External Web Site Policy: The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

Scope

Disease/Condition(s)

Infections associated with urologic surgery:

  • Surgical site infection
  • Urinary tract infection
Guideline Category
Prevention
Risk Assessment
Clinical Specialty
Internal Medicine
Preventive Medicine
Surgery
Urology
Intended Users
Physicians
Guideline Objective(s)

To assist urologists in the appropriate use of periprocedural antimicrobial prophylaxis

Target Population

Patients undergoing urologic surgery

Interventions and Practices Considered

Periprocedural systemic antimicrobial prophylaxis:

  • First, second, or third-generation cephalosporin
  • Fluoroquinolone
  • Aminoglycoside
  • Ampicillin
  • Trimethoprim-sulfamethoxazole (TMP-SMX)
  • Clindamycin
  • Metronidazole
  • Vancomycin
  • Amoxicillin/clavulanate
  • Ampicillin/sulbactam
  • Neomycin plus erythromycin base
  • Piperacillin/tazobactam
  • Ticarcillin/clavulanate
Major Outcomes Considered
  • Rate of postoperative infection
  • Cost, convenience, and safety of antimicrobial agents
  • Emergence of resistant bacterial strains

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

2007 Guideline

A Medline search was performed using the Medical Subject Headings (MeSH) index headings "antimicrobial prophylaxis," "postoperative complications," "surgical wound infection," "anti-bacterial agents," and the names of specific urologic procedures, from 1996 through 2006. This initial search was supplemented by scrutiny of bibliographies and additional focused searches, and 169 publications were selected for analysis by the Panel members. These included guidelines and policies from other groups, some of which were identified by Panel members outside of the Medline search; the guidelines from other groups were considered in the Panel's deliberations.

2010 Reaffirmation

Using search terms related to antimicrobial prophylaxis and urologic surgery, the Guidelines Medical Librarian conducted two database searches. The first search was conducted in PubMed, a Medline database, and the second search was conducted in Embase, a comprehensive biomedical database. The dates covered in the literature review ranged from January 1, 2007 to May 5, 2010. The Medline search identified 94 potentially relevant study articles, while the Embase search identified 421 potentially relevant study articles.

Inclusion/Exclusion Criteria

A preliminary abstract review was conducted among the 94 articles found via Medline search (PubMed), to assess relevance to the questions outlined by the Panel on the topic template. Due to the high number of studies identified by Embase, a preliminary title review was conducted among the 421 articles to determine which studies were relevant. Inclusion criteria were applied broadly at this stage to ensure that no possibly relevant article was excluded.

Next, 103 full text articles were reviewed for inclusion/exclusion, based on purpose of the review, principles, and guideline statements listed on the topic template. Using this procedure, 60 articles found via Medline search were rejected for lack of relevance, and 32 articles were accepted. In addition, 12 relevant articles were accepted from Embase based on article title review, seven of which were accepted as non-duplicates of the Medline accepted articles, and two articles was rejected. All reasons for exclusion included: the study did not address or specify the use of antimicrobial prophylaxis (or the prophylaxis mentioned were not within 48 hours of the surgery) (n=31); the study did not specify a urological procedure/surgery (n=21); the study consisted of a non-human trial (n=2); the surgery was out of the scope of the topic (i.e., gynecological procedure) (n=2); the study was an in-vitro study (n=2); the intention of the prophylaxis was to prevent tuberculosis recurrence (n=1); could not retrieve full text in English language (n=1); and finally the article was an editorial comment, and not a peer-reviewed study (n=1). In addition there was one review article, that is not summarized in this report. The selected articles were then categorized based on the guideline statement category to which they were related (A through M).

Number of Source Documents

A total of 169 publications were selected for analysis.

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Levels of Evidence

Ia Evidence obtained from meta-analysis of randomized trials

Ib Evidence obtained from at least one randomized trial

IIa Evidence obtained from at least one well-designed controlled study without randomization

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study

III Evidence obtained from well-designed nonexperimental studies, such as comparative studies, correlation studies, and case reports

IV Evidence obtained from expert committee reports, or opinions, or clinical experience of respected authorities

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Assessment of the literature by the American Urological Association (AUA) Practice Guidelines Committee suggested that insufficient information was available to derive a guideline statement on antimicrobial prophylaxis during urologic surgery based solely on literature meta-analyses. As such, the Panel was charged with developing a Best Practice Policy Statement, which uses published data in concert with expert opinion, but does not employ formal meta-analysis of the literature.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The American Urological Association (AUA) convened the Urologic Surgery Antimicrobial Prophylaxis Best Practice Policy Panel, comprised of six urologists, to formulate recommendations for the use of antimicrobial prophylaxis during urologic surgery. The Panel formulated recommendations based on review of all material and the Panel members' expert opinions. Levels of evidence were assigned (see the "Rating Scheme for the Strength of the Evidence" field).

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Published cost analyses were reviewed.

Data regarding the costs associated with prophylactic antimicrobial use specifically for urologic surgery are not readily obtainable, but data from other surgical disciplines are enlightening. Clearly, surgical site infections (SSIs) are associated with poorer patient outcome and increased costs. A review of the outcomes of 3,864 surgical patients (general, cardiothoracic, and neurosurgical) showed an overall nosocomial infection rate of 11.3%. Even after accounting for covariates, nosocomial infection was associated with increased postoperative length of stay, hospital readmission rate, and outpatient use of antimicrobial agents - all of which significantly increased costs and utilization of medical resources. A recent large review of data from European centers confirmed the great cost of SSIs. Moreover, it has also been demonstrated in a variety of settings that surgical antimicrobial prophylaxis, by reducing the incidence of SSIs, reduces costs. Conversely, excess and/or inappropriate antimicrobial prophylaxis increase costs, which is reversed by measures to improve compliance with evidence-based recommendations.

Prophylactic antimicrobial use is associated with financial, personal-health and public-health costs. Included in the consideration of the financial impact are the expense of the agent, route of administration, associated administration supplies, and labor. Costs vary widely with the antimicrobial agent selected and also according to the setting in which the administration occurs. Another important factor is variation in the duration of antimicrobial prophylaxis. A single preoperative administration has less total associated cost than a cycle of three administrations during the 24-hour perioperative period. Finally, the ultimate financial cost of antimicrobial prophylaxis incorporates both the costs associated with the agent and the costs associated with patient outcomes (SSIs, adverse reactions, etc.). Comprehensive cost differences between different regimens can be demonstrated.

The personal-health risks of prophylactic antimicrobial administration include allergic reactions, which vary from minor rashes to anaphylaxis, and suppression of normal bacterial flora, which can lead to Clostridium difficile colitis, colonization and infection with resistant organisms, and other adverse effects. Although the frequency of adverse events for any specific antimicrobial agent is calculable for population exposures, it is difficult to assess the gravity of each adverse event, as well as the need for specific interventions to treat consequences of the adverse events. Nevertheless, all of these factors are components of the financial impact of prophylactic antimicrobial use. In general, the financial costs of prophylaxis are controlled by using the least expensive and safest efficacious agent for the shortest duration that is consistent with good clinical practice.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

This document was submitted for peer review, and comments from all 20 responding physicians and researchers were considered by the Panel in making revisions. The final document was submitted to the American Urological Association (AUA) Practice Guidelines Committee and Board of Directors for approval.

Recommendations

Major Recommendations

Definitions of the strength of the evidence (Ia – IV) are defined at the end of the "Major Recommendations" field.

Note from the American Urological Association (AUA) and the National Guideline Clearinghouse (NGC): The table of recommended antimicrobial prophylaxis for urologic procedures, below, was updated in September 2012 to include the use of cephalosporin for transrectal biopsies.

Principles of Surgical Antimicrobial Prophylaxis

  1. Surgical antimicrobial prophylaxis is the periprocedural systemic administration of an antimicrobial agent intended to reduce the risk of postprocedural local and systemic infections.
  2. The potential benefit of surgical antimicrobial prophylaxis is determined by three considerations: patient-related factors (ability of the host to respond to bacterial invasion), procedural factors (likelihood of bacterial invasion at the operative site), and the potential morbidity of infection.
  3. Surgical antimicrobial prophylaxis is recommended only when the potential benefit exceeds the risks and anticipated costs.
  4. The antimicrobial agent used for prophylaxis should be effective against the disease-relevant bacterial flora characteristic of the operative site. Cost, convenience, and safety of the agent also should be considered.
  5. The duration of surgical antimicrobial prophylaxis should extend throughout the period in which bacterial invasion is facilitated and/or is likely to establish an infection.

Table. Recommended Antimicrobial Prophylaxis for Urologic Procedures

Procedure Organisms Prophylaxis Indicated Antimicrobial(s) of Choice Alternative Antimicrobial(s) Duration of Therapy1
Lower Tract Instrumentation
Removal of external urinary catheter (Level of evidence: Ib, III, IV) GU tract2 If risk factors3,4
  • Fluoroquinolone5
  • TMP-SMX5
  • Aminoglycoside (Aztreonam6) + Ampicillin5
  • 1st/2nd gen. Cephalosporin5
  • Amoxicillin/Clavulanate5
≤24 hours5
Cystography, urodynamic study, or simple cystourethroscopy (Level of evidence: Ib, III, IV) GU tract If risk factors4
  • Fluoroquinolone
  • TMP-SMX
  • Aminoglycoside (Aztreonam6) + Ampicillin
  • 1st/2nd gen. Cephalosporin
  • Amoxicillin/Clavulanate
≤24 hours
Cystourethroscopy with manipulation7 (Level of evidence: Ia/b, IV) GU tract All
  • Fluoroquinolone
  • TMP-SMX
  • Aminoglycoside (Aztreonam6) + Ampicillin
  • 1st/2nd gen. Cephalosporin
  • Amoxicillin/Clavulanate
≤24 hours
Prostate brachytherapy or cryotherapy (Level of evidence: III, IV) Skin Uncertain
  • 1st gen. Cephalosporin
  • Clindamycin8
≤24 hours
Transrectal prostate biopsy (Level of evidence: Ib) Intestine9 All
  • Fluoroquinolone
  • 1st/2nd/3rd gen. Cephalosporin
  • Aminoglycoside (Aztreonam6) + Metronidazole or Clindamycin8
≤24 hours
Upper Tract Instrumentation
Shock-wave lithotripsy (Level of evidence: Ia) GU tract All
  • Fluoroquinolone
  • TMP-SMX
  • Aminoglycoside (Aztreonam6) + Ampicillin
  • 1st/2nd gen. Cephalosporin
  • Amoxicillin/Clavulanate
≤24 hours
Percutaneous renal surgery (Level of evidence: IIb, III) GU tract and skin10 All
  • 1st/2nd gen. Cephalosporin
  • Aminoglycoside (Aztreonam6) + Metronidazole or Clindamycin
  • Ampicillin/Sulbactam
  • Fluoroquinolone
≤24 hours
Ureteroscopy (Level of evidence: Ib) GU tract All
  • Fluoroquinolone
  • TMP-SMX
  • Aminoglycoside (Aztreonam6) + Ampicillin
  • 1st/2nd gen. Cephalosporin
  • Amoxicillin/Clavulanate
≤24 hours
Open or Laparoscopic Surgery
Vaginal surgery (Level of evidence: Ia/b, IIb) GU tract, skin, and Group B Strep. All
  • 1st/2nd gen. Cephalosporin
  • Aminoglycoside (Aztreonam6) + Metronidazole or Clindamycin
  • Ampicillin/Sulbactam
  • Fluoroquinolone
≤24 hours
Without entering urinary tract (Level of evidence: Ib, III, IV) Skin If risk factors
  • 1st gen. Cephalosporin
  • Clindamycin
Single dose
Involving entry into urinary tract (Level of evidence: Ib, III, IV) GU tract and skin All
  • 1st/2nd gen. Cephalosporin
  • Aminoglycoside (Aztreonam6) + Metronidazole or Clindamycin
  • Ampicillin/Sulbactam
  • Fluoroquinolone
≤24 hours
Involving intestine11 (Level of evidence: Ia, IV) GU tract, skin, and intestine All
  • 2nd/3rd gen. Cephalosporin
  • Aminoglycoside (Aztreonam6) + Metronidazole or Clindamycin
  • Ampicillin/Sulbactam
  • Ticarcillin/Clavulanate
  • Piperacillin/Tazobactam
  • Fluoroquinolone
≤24 hours
Involving implanted prosthesis (Level of evidence: Ia, IV) GU tract and skin All
  • Aminoglycoside (Aztreonam6) + 1st/2nd gen. Cephalosporin or Vancomycin
  • Ampicillin/Sulbactam
  • Ticarcillin/Clavulanate
  • Piperacillin/Tazobactam
≤24 hours

Order of agents in each column is not indicative of preference. The absence of an agent does not preclude its appropriate use depending on specific situations.

1Additional antimicrobial therapy may be recommended at the time of removal of an externalized urinary catheter.

2GU tract: Common urinary tract organisms are Escherichia coli, Proteus species (sp.), Klebsiella sp., Enterococcus.

3See Table 1 in the original guideline document "Patient-related factors affecting host response to surgical infections."

4If urine culture shows no growth prior to the procedure, antimicrobial prophylaxis is not necessary.

5Or full course of culture-directed antimicrobials for documented infection (which is treatment, not prophylaxis).

6Aztreonam can be substituted for aminoglycosides in patients with renal insufficiency.

7Includes transurethral resection of bladder tumor and prostate, and any biopsy, resection, fulguration, foreign body removal, urethral dilation or urethrotomy, or ureteral instrumentation including catheterization or stent placement/removal.

8Clindamycin, or aminoglycoside + metronidazole or clindamycin, are general alternatives to penicillins and cephalosporins in patients with penicillin allergy, even when not specifically listed.

9Intestine: Common intestinal organisms are E. coli, Klebsiella sp., Enterobacter, Serratia sp., Proteus sp., Enterococcus, and Anaerobes.

10Skin: Common skin organisms are Staph. aureus, coagulase negative Staph. sp., Group A Strep. sp.

11For surgery involving the colon, bowel preparation with oral neomycin plus either erythromycin base or metronidazole can be added to or substituted for systemic agents.

Abbreviations: gen, generation; GU, genitourinary; sp, species; Staph., Staphylococcus; Strep., Streptococcus; TMP-SMX, trimethoprim-sulfamethoxazole.

Refer to Table 3b in the original guideline document for information on recommended dosages of prophylactic antimicrobial agents.

Table. Antimicrobial Prophylaxis for Patients with Orthopedic Conditions

  • Antimicrobial prophylaxis is not indicated for urologic patients on the basis of orthopedic pins, plates, and screws, nor is it routinely indicated for most urologic patients with total joint replacements on that basis alone.
  • Antimicrobial prophylaxis intended to reduce the risk of hematogenous total joint infection is recommended in patients who meet BOTH sets of criteria in the table below. The recommended antimicrobial regimen in these patients include:
    • A single systemic level dose of a quinolone (e.g., ciprofloxacin, 500 mg; levofloxacin, 500 mg; ofloxacin, 400 mg) orally one to two hours preoperatively.
    • Ampicillin 2 g intravenous (IV) (or vancomycin 1 g IV over one to two hours in patients allergic to ampicillin) plus gentamicin 1.5 mg/kg IV 30 to 60 minutes preoperatively.
    • For some procedures, additional or alternative agents may be considered for prophylaxis against specific organisms and/or other infections.
  • For patients NOT meeting BOTH of these criteria, antimicrobial prophylaxis still may be indicated to reduce the risk of other infections.
Increased Risk of Hematogenous Total Joint Infection Increased Risk of Bacteremia Associated with Urologic Procedures
  • Patients during the first two years after prosthetic joint replacement
  • Immunocompromised patients with prosthetic joint replacements
    • Inflammatory arthropathies (e.g., rheumatoid arthritis, systemic lupus erythematosus)
    • Drug-induced immunosuppression
    • Radiation-induced immunosuppression
  • Patients with prosthetic joint replacements and comorbidities
    • Previous prosthetic joint infections
    • Malnourishment
    • Hemophilia
    • Human immunodeficiency virus (HIV) infection
    • Diabetes
    • Malignancy
  • Any stone manipulation (includes shock-wave lithotripsy)
  • Any procedure with transmural incision into urinary tract (does not include simple ligation with excision or percutaneous drainage procedure)
  • Any endoscopic procedures of upper tract (ureter and kidney)
  • Any procedure that includes bowel segments
  • Transrectal prostate biopsy
  • Any procedure with entry into the urinary tract (except for urethral catheterization) in individuals with higher risk of bacterial colonization:
    • Indwelling catheter or intermittent catheterization
    • Indwelling ureteral stent
    • Urinary retention
    • History of recent/recurrent urinary tract infection or prostatitis
    • Urinary diversion

Adapted from American Urological Association; American Academy of Orthopaedic Surgeons: Antimicrobial prophylaxis for urological patients with total joint replacements. J Urol 2003; 169:1796.

Definitions:

Levels of Evidence

Ia Evidence obtained from meta-analysis of randomized trials

Ib Evidence obtained from at least one randomized trial

IIa Evidence obtained from at least one well-designed controlled study without randomization

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study

III Evidence obtained from well-designed nonexperimental studies, such as comparative studies, correlation studies, and case reports

IV Evidence obtained from expert committee reports, or opinions, or clinical experience of respected authorities

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each antimicrobial prophylaxis recommendation (see Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Reduction of the risk of and improved prevention of postprocedural local or systemic infections following urologic surgery
  • Appropriate use of periprocedural antimicrobial prophylaxis
Potential Harms
  • The personal-health risks of prophylactic antimicrobial administration include allergic reactions, which vary from minor rashes to anaphylaxis, and suppression of normal bacterial flora, which can lead to Clostridium difficile colitis, colonization and infection with resistant organisms, and other adverse effects.
  • The public-health risk of antimicrobial prophylaxis relates to the induction of bacterial resistance in the patient and in the community microbial reservoir. Antimicrobial usage has had a clear impact on the emergence of resistant bacterial strains.

Qualifying Statements

Qualifying Statements

The decision to use antimicrobial prophylaxis in urological surgery and the selection of agent and dosing can start with guidelines such as the ones presented in this document. The appropriate use of antimicrobial prophylaxis in an individual patient, however, requires consideration of not only these guidelines but also a comprehensive evaluation of the patient's specific circumstances.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
American Urological Association Education and Research, Inc. Best practice policy statement on urologic surgery antimicrobial prophylaxis. Baltimore (MD): American Urological Association Education and Research, Inc.; 2007. 45 p. [100 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2007 Jan (reaffirmed 2010)
Guideline Developer(s)
American Urological Association Education and Research, Inc. - Medical Specialty Society
Source(s) of Funding

American Urological Association Education and Research, Inc. (AUA)

Guideline Committee

AUA Antimicrobial Prophylaxis Panel

Composition of Group That Authored the Guideline

Panel Members: J. Stuart Wolf, Jr., MD, Chairman; Carol J. Bennett, MD; Roger R. Dmochowski, MD; Brent K. Hollenbeck, MD, MS; Margaret S. Pearle, MD, PhD; Anthony J. Schaeffer, MD

Staff: Heddy Hubbard, PhD; Edith M. Budd; Michael Folmer; Katherine Moore; Kadiatu Kebe

Financial Disclosures/Conflicts of Interest

Members received no remuneration for their work. Each Panel member provided a conflict of interest disclosure to the American Urological Association (AUA).

Guideline Status

This is the current release of the guideline.

The American Urological Association Education and Research, Inc. reaffirmed the currency of the guideline in 2010.

Guideline Availability

Electronic copies: Available from the American Urological Association, Inc. (AUA) Web site External Web Site Policy.

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on March 21, 2008. The information was verified by the guideline developer on April 1, 2008. This summary was updated by ECRI Institute on July 28, 2008 following the U.S. Food and Drug Administration advisory on fluoroquinolone antimicrobial drugs. The currency of the guideline was reaffirmed by the developer in 2010 and this summary was updated by ECRI Institute on October 16, 2012. This summary was updated by ECRI Institute on October 25, 2013 following the U.S. Food and Drug Administration advisory on Fluoroquinolone Antibacterial Drugs.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the American Urological Association Education and Research, Inc. (AUA).

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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