Zomorrodi 2018.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: April 2016‐September 2016 |
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Participants |
Population: mixed Setting: Tabriz Country: Iran Inclusion criteria: all patients suffered from end‐stage renal failure and had negative urinary culture and had been operated by the same team of surgery using 3 medications (tacrolimus, prednisolone and mycophenolate mofetil) Exclusion criteria: any patient with history of lower urinary tract disease and abnormality of lower urinary tract and also any patient who disagreed with the study was excluded Condition for hospitalisation: renal transplantation for end stage renal failure Number of participants: eligible; 88 randomised; 88 reported Age (mean and SD): A 43.52 ± 13.6; B 43.20 ± 14.39 Use of antibiotic prophylaxis: not reported |
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Interventions |
Group A (n = 44): IUC removal 3 days post‐op Group B (n = 44): IUC removal 7 days post‐op 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: 3 days post‐op Group B: 7 days post‐op |
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Outcomes | UTI | |
Definition of CAUTI or bacteriuria | Not reported | |
Sponsorship/funding | This study was supported by Tabriz University of Medical Sciences, Tabriz, Iran. | |
Ethical approval | The research followed the tenets of the Declaration of Helsinki. Consent for operation and study had been taken. The ethical committee of Tabriz University of Medical Sciences approved the research. All patients’ information remained confidential. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “The patients were all divided into two groups randomly” Comment: unclear method of randomisation |
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. Assume lab technician blinded to participants of the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to be free from attrition bias |
Selective reporting (reporting bias) | Low risk | Appears to be free from reporting bias. Outcomes reported in protocol also reported in trial |
Other bias | Low risk | Appears to be free from other sources of bias |
APR: abdominoperineal resection; ASA: American Society of Anesthesiologists; AUA: American Urological Association; AUB: abnormal uterine bleeding; AUR: acute urinary retention; BP: blood pressure; CAUTI: catheter‐associated urinary tract infection; CDC: Centers for Disease Control and Prevention; cfu: colony forming unit; CS: caesarian section; DVT: deep vein thrombosis; EAU: European Association of Urology; FIGO: International Federation of Gynecology and Obstetrics; ICU: intensive care unit; IM: intramuscular(ly); IPSS: International Prostate Symptom Score; IQR: interquartile range; ITT: intention‐to‐treat; IUC: indwelling urethral catheter; IV: intravenous; LAR: low anterior resection; PCEA: patient‐controlled epidural anaesthesia; Post‐op: post‐operative(ly); PSA: prostate‐specific antigen; PTFE: polytetrafluoroethylene; QoL: quality of life; RCT: randomised controlled trial; RUV: residual urine volume; SD: standard deviation; TUIP: transurethral incision of the prostate; TURP: transurethral resection of the prostate; UTI: urinary tract infection; VAS: visual analogue scale