Benoist 1999.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: January 1994‐June 1997 |
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Participants |
Number of participants: eligible: not reported; 132 randomised; 126 reported Setting: Paris Country: France Population: mixed Age (mean (SD)): A 55 (18); B 56 (17) Inclusion criteria: patients undergoing extensive rectal resection (total or subtotal proctectomy) Condition for hospitalisation: rectal resection Exclusion criteria: patients receiving pre‐operative therapeutic antibiotics; suspected bladder tumour or urinary tract malignancies; previous IUC that ended < 48 h before insertion of the current catheter Use of antibiotic prophylaxis: as prophylaxis for bowel surgery, all patients were injected IV with a single dose of antibiotics on the induction of anaesthesia. |
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Interventions |
Group A (n = 64): IUC removal 1 day post‐op Group B (n = 62): IUC removal 5 days post‐op Size of catheter used: 14F catheter Type of indwelling catheter: not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: removal of IUC 1 day after surgery B: removal of IUC 5 days after surgery |
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Outcomes | AUR Chronic urinary retention UTI Long‐term urinary complications Patients undergoing total mesorectum excision |
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Definition of CAUTI or bacteriuria | Urinary infection was diagnosed if a culture yielded > 105 cfu/mL, with or without clinical symptoms | |
Sponsorship/funding | Not reported | |
Ethical approval | “…which was approved by the hospitals ethics committee” | |
Notes | AUR defined as absence of spontaneous micturition 12 h after catheter removal or after single intermittent catheterisation. Catheters were never clamped and were maintained on a closed drainage system. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “… patients were randomized into 1‐day or 5‐day urinary drainage groups according to the following computer‐generated randomization sequence.” Comment: adequate method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported Comment: unlikely blinding was possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Quote: “… urine samples from both groups were sent to a laboratory for culture” Comment: cultures were sent to a laboratory so it is unlikely that the microbiologist knew which samples corresponded to patients in the trial. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "...1 patient died postoperatively, 2 had postoperative complications requiring early reoperation, 2 inadvertently removed catheters, 1 required prolonged urine output monitoring because of transient respiratory failure requiring prolonged artificial ventilation." Comment: unclear what effect this has an the outcome of interest |
Selective reporting (reporting bias) | Low risk | All outcomes reported in methods was reported in results. Protocol not available |
Other bias | Low risk | Appears to be free from other sources of bias |