Skelly 1992.
Methods |
RCT or quasi‐RCT: RCT Setting: orthopaedic unit in a general hospital (St. Joseph’s Hospital, Hamilton, Ontario, Canada) Period: November 1986 – December 1987 |
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Participants |
Population: patients ≥ 60 years old admitted for surgical repair of hip fracture Inclusion criteria: patients ≥ 60 years old admitted for surgical repair of hip fracture Exclusion criteria: patients with intractable incontinence, patients admitted with indwelling catheter in place, patients who were unable to provide informed consent Age (mean, SD): A: 78 (8.2); B: 78 (8.6) Number of participants: · Eligible: 76 · Randomised: 67 · Reported: 67 Dropouts (n of participants + reasons): 5 medically unstable, 2 died before surgery, 2 did not have urinary retention after surgery Post‐randomisation: none reported Follow‐up: 5 days |
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Interventions |
Time of intervention: preoperative A (n = 35): indwelling catheter inserted preoperatively and left in place until 48 hours after surgery. If could not void in following 24 hours, intermittent catheterisation performed every 8 hours for 24 hours. If still not able to void indwelling catheter inserted again for 48 hours B (n = 32): intermittent catheter inserted every 6 ‐ 8 hours, with 400 ‐ 600 ml of urine removed each time Catheterisation stopped when residual volume of urine < 150 ml on 2 consecutive occasions Intended duration of catheterisation: A: 48 hours B: 5 postoperative days if normal voiding returned. If not, catheter remained in until voiding returned Voiding defined as > 100 ml and residual volume < 150 ml on 2 consecutive occasions |
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Outcomes |
Primary outcome (symptomatic UTI): not reported Definition of symptomatic UTI: not reported Bacteriuria: A: 11/35; B: 12/32 Definition of bacteriuria: ≥ 10⁵ cfu/ml on postoperative day 5 Postoperative urinary retention : A: 6/35; B: 6/32 Participants voiding on postoperative day 5: A: 13/35; B: 21/32 Days until return of voiding (mean, n): A: 9.4, 35; B: 5.1, 32 Incontinent after postoperative day 5: A: 5/35; B: 2/32 Quality of life: not reported |
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Sponsorship/Funding | “This work was supported by a research grant from Ontario Ministry of Health” | |
Notes | Not reported if used prophylactic antibiotics | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “use of a randomization technique involving block sizes of four” – method of randomisation not given, not clear if selection bias risk is high or low |
Allocation concealment (selection bias) | Low risk | “sequentially numbered sealed envelope” – adequate method of allocation concealment, low risk of selection bias |
Blinding of participants | High risk | No information given. As indwelling vs intermittent can assume blinding did not occur for participants, therefore high risk of bias |
Blinding of personnel | High risk | No information given. As indwelling vs intermittent can assume blinding did not occur for personnel, therefore high risk of bias |
Blinding of microbiological outcome assessment | Low risk | Bacteriuria would be assessed by microbiologist who would not know what catheter the participant had |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given. Primary outcome is urinary retention, but no method reported on how urinary retention was diagnosed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 76 agreed to participate in trial – 9 excluded (5 at physician’s request as medically unstable, 2 died before surgery, 2 did not have urinary retention). 67 randomised. All randomised participants included in analysis |
Selective reporting (reporting bias) | Unclear risk | No clear information given in Methods about the outcomes being studied. Unable to access protocol, so uncertainty surrounding reporting bias |
Other bias | Low risk | Appears to be free from other sources of bias |