Asuero 1989.
Methods |
Study design: prospective randomized control study Study dates: not available Setting: 1 hospital Country: Spain |
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Participants |
Inclusion criteria: people with negative preoperative urine cultures Exclusion criteria: allergy to penicillins, indwelling catheter, easily bleeding during manipulation Sample size: 46 Age (years): overall median: 65 (51–78) Sex: not available |
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Interventions |
Group 1 (n = 23): no antibiotic prophylaxis Group 2 (n = 23): cefuroxime 750 mg intravenously 1 hour preoperatively and 2 more doses administered at 12 and 24 hours after surgery |
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Outcomes |
Systemic UTI How measured: not reported Time points measured: not reported Time points reported: not reported Outcomes: no participant had symptoms suggestive of a UTI Asymptomatic bacteriuria How measured: not reported Time points measured: urine cultures performed on 5th day and 1 month postoperatively Time points reported: not reported Outcomes: control group: 16/23 participants had bacteriuria 5 days after cystoscopy, and 2/23 had bacteriuria 1 month after cystoscopy; treatment group: 3/23 had bacteriuria 5 days after cystoscopy, and 5/23 had bacteriuria 1 month after cystoscopy Bacterial resistance How measured: not reported Time points measured: bacteria cultures from urine performed 5 days after cystoscopy Time points reported: not reported Outcomes: control group: 16 participants with positive urine cultures, 9 of them they showed no sensitivity to cefuroxime; treatment group, 3 participants were all resistant |
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Funding sources | No information about funding | |
Declarations of interest | No information about conflict and interest | |
Notes | In the antibiotic prophylaxis group, all participants with negative blood cultures in the 3rd postoperative day, and 4 participants in the control group had bacteraemia. 3 participants showed an acute epididymitis after cystoscopy, but this study did not report which group they came from. No email address available for contacting the corresponding author for further information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "We have carried out a prospective study on 46 patients, these 46 patients were randomly divided into two groups." Comment: method for generation of random sequence not given. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information regarding the concealment of randomization. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "A first control group of 23 patients who were not administered antibiotic prophylaxis, a second group of 23 patients who were administered 750 mg." Comment: participants in control group were not administered antibiotic prophylaxis, while the treatment group receive intravenous antibiotic prophylaxis. Unlikely that participants and personnel were blinded to intervention. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote: "A first control group of 23 patients who were not administered antibiotic prophylaxis, a second group of 23 patients who were administered 750 mg." Comment: participants were not blinded to their treatment, the risk of detection bias for subjective outcomes, i.e. symptoms suggestive of UTI after cystoscopy was high. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "When cultures were positive postoperative urine, the sensitivity of the germ to cefuroxime titrated were tested." Comment: since bacterial resistance was evaluated by urine culture from laboratory, results were objective and probably not influenced by blinding or not. |
Incomplete outcome data (attrition bias) Systemic UTI | Low risk | Quote: "no participant had symptoms suggestive of a urinary tract infection." Comment: 46/46 participants (23 participants in each arm) included for analysis of this outcome, this risk of bias was low. |
Incomplete outcome data (attrition bias) Symptomatic UTI | Low risk | Quote: "no participant had symptoms suggestive of urinary tract infection." Comment: 46/46 participants (23 participants in each arm) included for analysis of this outcome, this risk of bias was low. |
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 | Unclear risk | Comment: outcome not reported. |
Incomplete outcome data (attrition bias) Asymptomatic bacteriuria | Low risk | Quote: "Urine cultures performed the 5th postoperative day were positive in three patients in the prophylaxis group (13%) remain negative in the remaining 20 (87%). By contrast, in the control group, these cultures were positive in 16 (69.6%) and negative in 7 of them (30.4%)." Comment: 46/46 participants (23 participants in each arm) included for analysis of this outcome, this risk of bias was low. |
Incomplete outcome data (attrition bias) Bacterial resistance | Low risk | Quote: "Three patients in the prophylaxis, isolated germs were resistant, whereas in the control group of 16 patients with positive urine cultures 9 of them they showed no sensitivity." Comment: all included participants were included for analysis of this outcome. 46/46 participants (23 participants in each arm) included for analysis of this outcome, this risk of bias was low. |
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. |