O'Kelly 1995.
Methods |
RCT or quasi‐RCT: RCT Setting: UK |
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Participants |
Population: patients undergoing abdominal surgery Inclusion criteria: patients undergoing abdominal surgery and a full‐length abdominal incision Comment: It is not clear whether patients with initial positive urine cultures were excluded Exclusion criteria: not reported Age (median, range): A: 65 (42 ‐ 81) years; B: 68 (35 ‐ 79) years Number of participants:
Dropouts (n of participants + reasons): 5 participants:2 died shortly after operation and in 3 participants no catheter was inserted. Authors did not report from which group participants were lost |
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Interventions | A (n = 29): Indwelling urethral catheterisation (14 French) before operation B (n = 28): Suprapubic catheterisation (14 French) after the abdomen was opened Duration of intervention: Catheters were removed when this was appropriate on clinical grounds, but it was recommended that suprapubic catheters should remain in place until the 5th postoperative day. Before removal the SPC was clamped and was withdrawn when the participant could micturate spontaneously and the residual urine was < 100 ml |
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Outcomes |
Primary outcome (symptomatic UTI): not reported Bacteriuria: A: 3/29; B: 3/28 Definition of bacteriuria: Significant bacteriuria was defined as > 105 cfu/ml. Specimens were daily aspirated from the catheter and a final midstream was obtained 2 days after the catheter was removed Recatheterisation: A: 2/29; B: 1/28 Duration of catheterisation (median): A: 4 days (range 2 ‐ 11); B: 5 days (range 4 ‐ 10) Number of participants with pain: A: 13/29; B: 2/28 Number of catheter days with pain: A: 37/126; B: 6/142 |
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Sponsorship/Funding | Not reported | |
Notes | Each participant kept a daily record of catheter‐related pain, scoring discomfort on a standard VAS (no pain = 0; worst possible pain = 10) Not reported whether prophylactic antibiotics were used |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "62 patients were randomized into two groups" ‐ no information given on method of randomisation |
Allocation concealment (selection bias) | Unclear risk | No method of allocation concealment given |
Blinding of participants | High risk | No information given but as suprapubic vs urethral can assume blinding of participants did not occur |
Blinding of personnel | High risk | "All catheters were inserted by the surgeon in the operating theatre" ‐ based on this statement, can assume surgeons not blinded "patients were reviewed each day by one of the authors (T.J.O.K. or A. Mathew)" ‐ based on this statement, can assume authors not blinded |
Blinding of microbiological outcome assessment | Low risk | Symptomatic UTI assessed by microbiologist who would not know the route of catheter the participant had inserted |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two patients died shortly after operation and in three cases a catheter was not inserted" ‐ reason unlikely to be related to true outcome |
Selective reporting (reporting bias) | Low risk | Methods gives some details of what data will be measured, for which there are results. Unable to access protocol, so some uncertainty about selective reporting |
Other bias | Low risk | Appears to be free from other sources of bias |