Knight 1996.
Methods |
RCT or quasi‐RCT: RCT Setting: USA |
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Participants |
Population: patients undergoing total hip or knee arthroplasty Inclusion criteria:patients undergoing a primary total hip arthroplasty or total knee arthroplasty with sterile urine cultures Exclusion criteria:History of chronic UTIs or a structural urinary abnormality, revision arthroplasty, long‐term suppressive antibiotic therapy Age (mean, range): 66 (35 ‐ 86) years. Number of participants:
Dropouts (n of participants + reasons): 55 participants were excluded: 35 did not have cultures obtained on postoperative day 5; 5 allocated to treatment group received a urethral catheter; 7 allocated to control group received an IC; 8 required prolonged use of a urethral catheter for medical reasons Follow‐up: until participants were voiding without problems |
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Interventions | A (n = 62): Indwelling urethral catheter (Foley) placed just prior to surgery. Remained in place for 48 hours.
Thereafter, urinary retention was treated with intermittent catheterisation. B (n = 57): Intermittent catheterisation every 6 hours if participants were unable to void or were voiding in volumes of ≤ 50 ml. |
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Outcomes |
Primary outcome (symptomatic UTI): not reported Bacteriuria: A: 5/62; B: 7/57 (P = 0.45) Definition of bacteriuria: > 105 colonies of a predominant organism Number of participants with urinary retention 48 hours after surgery: A:12/62; B:20/57 Costs per participant for the first 48 hours after surgery: A: USD 8.33; B: USD 53.20 |
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Sponsorship/Funding | Not reported | |
Notes | Urinary retention was defined as the inability to pass urine or if participants were voiding in volumes of ≤ 50 ml
Analysis of cost was conducted for the 2 methods of management based on both materials and nursing time components of costs. Antibiotics: All participants received routine antibiotic prophylaxis (cefazolin) every 8 hours for 48 hours; it was not explicitly stated whether other antibiotics except prophylaxis were administered pre‐ or postoperatively. Participant‐controlled analgesia was given to those who had a general anaesthetic. Participants who had an epidural anaesthetic were maintained on the epidural for analgesia for 48 hours. The average number of intermittent catheterisations was 8 per participant (participants were catheterised more frequently than the planned 6‐hour trial interval) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | “Eligible patients were randomized into one of two groups according to the last digit of their medical record number without regard to age, sex or procedure” – sequence generated by rule based on medical record number; not truly random |
Allocation concealment (selection bias) | High risk | “Eligible patients were randomized into one of two groups according to the last digit of their medical record number without regard to age, sex or procedure” – allocation not concealed as participant could be identified by medical record number |
Blinding of participants | High risk | No information provided but can assume participants were not blinded as indwelling vs intermittent |
Blinding of personnel | High risk | “Patients... received an indwelling Foley catheter in the operating room just prior to start of surgery” “Patients… were intermittently straight catheterized every six hours” – can assume that clinicians were not blinded during insertion of catheter and in postoperative care |
Blinding of microbiological outcome assessment | Low risk | Urine culture for symptomatic UTI would be assessed by microbiologist, who would not know the allocation of participant to either type of catheter |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given for other outcomes |
Incomplete outcome data (attrition bias) All outcomes | High risk | “Fifty‐five patients who were enrolled in the trial were eliminated for various reasons: 35 patients did not have cultures obtained on postoperative day 5; five patients to be in group 2 received a Foley; 7 patients to be in group 1 did not receive a Foley catheter; eight patients required prolonged use of a Foley catheter (to accurately monitor intake and output) for medical reasons.” – dropout rate of 55 participants is high. |
Selective reporting (reporting bias) | Low risk | Reported all expected outcomes. Unable to access protocol, some uncertainty about selective reporting |
Other bias | Unclear risk | "five patients to be in group 2 received a Foley, 7 patients to be in group 1 did not receive a Foley" ‐ these participants were excluded from analysis |