Chia 2009.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: not reported |
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Participants |
Number of participants: eligible – not reported; 80 randomised (40 in each group); 78 reported Setting: Taiwan Population: mixed Age (e.g. mean and SD): A 54.7 ± 11.2; B 55.7 ± 10.3 Inclusion criteria: patients of ASA physical status I−III undergoing thoracotomy Condition for hospitalisation: thoracotomy Exclusion criteria: urological/spinal/cardiopulmonary/neurological diseases; coagulopathy and/or any medication that might interfere with the sympathetic nervous system or micturition were excluded from this study Use of antibiotic prophylaxis: a single dose of prophylactic antibiotic was given IV in all participants |
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Interventions |
Group A: IUC removed on the 1st post‐operative day (n = 38) Group B: IUC removed after discontinuation of PCEA (3rd post‐operative day) (n = 40) Size and type and type of catheter used: 14F Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC removed on the 1st post‐operative day B: IUC removed on the 3rd post‐operative day |
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Outcomes | Recatheterisation for urinary retention CAUTI Average duration of bladder drainage Pain intensity at rest (VAS) Urethral pain intensity (VAS) |
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Definition of CAUTI or bacteriuria | Not reported | |
Sponsorship/funding | Not reported | |
Ethical approval | “After obtaining approval from the Human Investigation Committee at Kaohsiung Veterans General Hospital and written informed consent from all patients.” | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “…the eligible patients were randomly assigned into two groups according to a table of random numbers generated by a computer.” 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. Unlikely, blinding was not possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | No information given, but can assume urine sample was assessed by microbiologist who would not know allocation of participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “two patients in group 1 were excluded due to inadequate pain relief by postoperative PCEA” Comment: low number of participants excluded |
Selective reporting (reporting bias) | Unclear risk | Data reported graphically in way that did not allow precise data extraction – VAS scores were reported as significant without P values or the mean VAS scores presented in the figures |
Other bias | Low risk | Appears to be free from other sources of bias |