Dissections INTERVENTIONAL

22 April 2009
Evidence-based Medicine for Surgeons

Antibiotic prophylaxis at urinary catheter removal prevents urinary tract infections

Authors: Pfefferkorn U, Lea S, Moldenhauer J, et al
Journal: Annals of Surgery 2009; 249:573–575
Centre: Department of Surgery, St Claraspital, Basel, Switzerland
Catheter-associated urinary tract infections are the most common healthcare-associated
(nosocomial) infections seen in surgical practice. Even though the prevalence of bacteruria
BACKGROUND increases by 3-10% per day of catheterization, it is currently accepted that indwelling urinary
catheters should not be covered by antibiotics during their period of usage. However, the role and
value of prophylactic antibiotic administration at the time of catheter removal is controversial.
Authors' claim(s): “...we suggest the use of antibiotic prophylaxis at urinary
RESEARCH QUESTION catheter removal to prevent a common, in most cases inconvenient but
potentially harmful, complication.”
Population
Patients undergoing elective IN SUMMARY
abdominal surgery at a single
centre with planned perioperative Primary and secondary endpoints: results
urethral catheterization With prophylaxis (103) No prophylaxis (102)
Indicator variable Symptomatic UTI after 5 (4.9%) 22 (21.6%)
catheter removal (p <0.001)
Three doses of trimethoprim-
sulfamethoxazole at urinary Significant bacteruria after 17 (16.5%) 42 (41.2%)
catheter removal. catheter removal (p < 0.001)

Outcome variable Significant bacteruria before 39 (37.7%) 35 (34.3%)

catheter removal (p = 0.66)
Primary: occurrence of urinary
tract infection after catheter
removal. Secondary: occurrence of The absolute risk reduction for the occurrence of a urinary tract infection
asymptomatic bacteruria. was 16.7% (CI: 7.8%–22.1%).
The number needed to treat (NNT)was 6 (CI: 4.5–12.8). Six patients have
Comparison to be treated with antibiotic at catheter removal to prevent one infection.
No antibiotic prophylaxis.

THE BOTTOM LINE

This is a gem of a study that appears to have done everything right. The research question is precise and sharply focused.
The study design and statistical analysis leaves little room for objections. Shortcomings of the study are listed and
addressed squarely. The issues at hand are common and important. This study needs to be incorporated into our clinical
practices.

EBM-O-METER
Evidence level Overall rating Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interestingl | Novel l | Feasible l
Case series - retrospective  Ethical l | Resource saving l

The devil is in the details (more on the paper) ... 

© Dr Arjun Rajagopalan
 SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random Patients undergoing Received antibiotic Study Controls
elective abdominal coverage > 48 hours
Stratified random Target ? ?
surgery with planned during catheterization
Cluster perioperative urethral  Accessible ? ?
catheterization  Received antibiotics
Consecutive after catheter removal Intended 119 119

Convenience Drop outs 16 17
Patients not
Judgmental completing all tests  Study 103 102

 = Reasonable | ? = Arguable |  = Questionable

To detect a 10% difference with a significance level of 0.05 and statistical power of 80%, 220 patients were required.

Sampling bias: The drop out rate of 14% is high, but the drop outs were similar in characteristics in either arm.
The study is a single centre experience limited to patients undergoing abdominal surgery (predominantly colorectal).

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details At admission patients were consecutively randomized into 2 groups. One group received 960
mg trimethoprim-sulfamethoxazole orally once the night before, and twice on the day of
catheter removal. Ciprofloxacin 250 mg was used as a replacement in patients with known
allergy to trimethoprim-sulfamethoxazole. Patients in the other group did not receive any
prophylaxis. Urinary cultures were obtained the day before and 3 days after catheter removal.
Comparability The two groups were similar in demographic characteristics and co-morbidties. The urinary
catheters were left in place for 7 +/- 1.7 days in the group with prophylaxis and for 6.5 +/-
1.7 days in the group without prophylaxis, (p = 0.68). There were no significant differences
between the groups of patients who were excluded from the study after randomization.
Disparity No significant differences in the overall population or drop outs.

Comparison bias: No detectable flaws.

MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.

Device suited to task

Training

Scoring

Blinding
Repetition

Protocols

Y ? N

1.Symptom assessment: before discharge, Y N Y Y - - Y

patients were seen by a study-blind specialist in
urology to assess subjective symptoms before and
after catheter removal.
2.Significant urinary tract infection: patients with Y N Y - Y - -
positive urine culture (>105 microorganisms per
cm3) and at least one of the following signs or
symptoms with no other recognized cause: fever
(>38°C), urgency, frequency, dysuria, or
suprapubic tenderness.
3.Asymptomatic bacteriuria, which was diagnosed Y N Y - y - -
in patients with positive urinary culture but none of
the earlier mentioned signs or symptoms.

Measurement bias: Nothing to complain about.

© Dr Arjun Rajagopalan