Lista 2020.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: September 2016‐May 2017 |
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| Participants |
Population: men Setting: Milan Country: Italy Inclusion criteria: inclusion criteria were age ≤ 75 years, signed informed consent, and absence of contraindications to robotic surgery. Furthermore, only patients with a negative leakage test, performed intraoperatively with intravesical administration of 250 cc of diluted methylene blue, were included. Condition for hospitalisation: robot‐assisted radical prostatectomy for localised prostate cancer Exclusion criteria: previous prostatic or urethral surgery, previous pelvic radiation therapy, presence of urethral disease (e.g. urethral strictures and diverticulum), and pre‐existing urinary stress, urge, or mixed incontinence Number of participants: 206 eligible; 176 randomised; 146 reported Age (median and range): A 63 (48‐75); B 64 (45–75) Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 72): IUC removal post‐op day 3 Group B (n = 74): IUC removal post‐op day 5 Size and type of catheter used: not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: removal 3 days post‐op Group B: removal 5 days post‐op |
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| Outcomes | AUR Length of hospital stay UTI at 30 days |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | None | |
| Ethical approval | After Ethical Committee approval (internal protocol no. 1624) | |
| Notes | "In addition, the economic impact of this strategy has been evaluated. A significant reduction in costs was observed in group 1, with €296 saved per patient and with a total amount of approximately €80 000 saved yearly.Considering also the potential number of hospital beds gained, it has been estimated that almost €320 000 per year could be saved as an additional benefit". | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “were randomly allocated with a 1:1 ratio to the two study arms” Comment: method of randomisation unclear |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely given nature of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported. It is likely that urine samples were sent to a laboratory where the microbiologist would be blinded to participants involved in the trial |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Figure 1 illustrates 7 participants lost to follow‐up with no clear explanation |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in methods section and protocol reported |
| Other bias | Low risk | Appears to be free from other sources of bias |