Cam 2009.
Methods |
Study design: parallel‐group, prospective randomized trial Study dates: not available Setting: 1 hospital Country: Turkey |
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Participants |
Inclusion criteria: people undergoing diagnostic cystoscopy for check‐up of a superficial bladder tumour; people with subsequent incidental interventions, including punch biopsy and transurethral resection of a small bladder tumour; people with initial negative urine cultures Exclusion criteria: used antibiotics for any reason during last month. Moreover, people requiring antibiotic prophylaxis for infective endocarditis or those with positive urine cultures were excluded Sample size: 200 participants randomized Age (years): mean control group: 56.3 (SD 5.4); mean prophylaxis group: 58.9 (SD 5.2) Sex: control group: 59 men and 41 women; prophylaxis group: 62 men and 38 women |
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Interventions |
Group 1 (n = 100): antibiotic prophylaxis, intravenous, single dose 1 g, at the time of induction of anaesthesia Group 2 (n = 100): no antibiotic prophylaxis |
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Outcomes |
Systemic UTI How measured: participants had a follow‐up visit at the first month after cystoscopy; clinical parameters including fever, dysuria, and frequency evaluated Time points measured: within 30 days after cystoscopy Time points reported: within 30 days after cystoscopy Outcomes: no fever or any other severe symptom was detected in any participant Localized UTI How measured: participants with positive urine cultures had complaints of dysuria and frequency Time points measured: urine culture tested 1 day after cystoscopy Time points reported: not available Outcomes: placebo group: 1/100 had localized symptom and positive urine culture 1 day after cystoscopy; treatment group: 1/100 had localized symptom and positive urine culture 1 day after cystoscopy Asymptomatic bacteriuria How measured: participants with positive urine culture and no symptoms Time points measured: urine culture tested 1 day after cystoscopy Time points reported: not reported Outcomes: control group: 1/100 had asymptomatic bacteriuria; treatment group: 0/100 had asymptomatic bacteriuria |
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Funding sources | No information about funding | |
Declarations of interest | No information about conflict and interest | |
Notes | Used rigid cystoscopes. 2 participants, 1 from each group, had dysuria without associated positive culture results. We tried to contact corresponding author about allocation concealment, but we received no response. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using tables of random numbers and using a block randomization." Comment: random sequence generation performed adequately. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information regarding concealment of randomization. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The first group received no antibiotic prophylaxis, the second group had a single dose of intravenous cefoperazone (1 g)." Comment: participants in control group were not administered antibiotic prophylaxis, while the treatment group received intravenously antibiotic prophylaxis. Unlikely that participants and personnel were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote: "The first group received no antibiotic prophylaxis, the second group had a single dose of intravenous cefoperazone (1 g)." Comment: participants were not blinded to their treatment. Risk of detection bias for systemic UTI, localized UTI and asymptomatic bacteriuria was high. |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: not applicable, since the objective outcome of drug resistance was not reported. |
Incomplete outcome data (attrition bias) Systemic UTI | Low risk | Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications." Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Symptomatic UTI | Low risk | Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications." Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Serious adverse events | Unclear risk | Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Minor adverse events | Unclear risk | Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Localized UTI | Low risk | Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications." Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Asymptomatic bacteriuria | Low risk | Quote: "No statistical difference was detected regarding age and gender between the groups, two groups were similar with regard to the distribution of cystoscopy indications." Comment: 200/200 randomized participants (100 participants in each arm) were included for analysis of this outcome. |
Incomplete outcome data (attrition bias) Bacterial resistance | Unclear risk | Comment: outcome not reported. |
Selective reporting (reporting bias) | Unclear risk | Comment: data reported on all outcomes specified in methods section, but there was no access to trial protocol/registration to further assess selective reporting. |
Other bias | Low risk | Comment: no other bias detected. |