Joshi 2014.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: July 2008‐December 2009 |
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Participants |
Number of participants: eligible, not reported; 70 randomised; 70 reported Setting: Chandigarh Country: India Population: women Age (mean ±SD): A 46.80 ± 6.90; B 45.09 ± 6.44 Inclusion criteria: women undergoing uneventful abdominal hysterectomy with or without salpingo‐oophorectomy Condition for hospitalisation: abdominal hysterectomy with or without salpingo‐oophorectomy Exclusion criteria: anticipated complicated surgical procedure requiring strict fluid replacement post‐operatively; bladder suspension or colporrhaphy surgery; positive or unavailable pre‐operative urine culture report; comorbid illness requiring strict intake output monitoring Use of antibiotic prophylaxis: all patients received 1 dose of antibiotic prophylaxis at the time of surgery and continued post‐operatively as per department protocol |
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Interventions |
Group A (n = 35): immediate removal of IUC in the operating room Group B (n = 35): IUC removal after 24 h Size and type of catheter used (e.g. Foley 16F): standard 16F Foley’s catheter with 10 cc balloon Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: immediate removal of IUC in the operating room B: removal of IUC 24 h post‐operatively |
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Outcomes | Recatheterisation (defined as inability to pass urine at the end of 12 h, or failure to void after 2 attempts) Positive urine culture on day 2 post‐op Positive urine culture 2 weeks post‐op Febrile morbidity Pain perception |
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Definition of CAUTI or bacteriuria | “The diagnosis of symptomatic UTI was based on the presence of significant bacteriuria accompanied by at least one of the following symptoms: Fever, dysuria, increased frequency of urination, urinary urgency, suprapubic pain, and burning micturition.” | |
Sponsorship/funding | Not reported | |
Ethical approval | “Informed consent was obtained from enrolled patients and protocol was approved by the Institute’s Ethical Committee.” | |
Notes | Pain was assessed with a pictorial questionnaire that assessed the level of pain and location of pain, that is, bladder or urethra versus surgical site. The questionnaires were site‐specific for the pain. All patients were given same analgesia in the post‐operative period. Febrile morbidity was defined as 2 consecutive oral temperatures of > 100.4 °F (37.78 °C) measured 6 h apart. Of 12 culture‐positive most common organism was Escherichia coli. None of these had repeat culture‐positive at 2 weeks. 3/9 culture‐positive cases in late removal group had symptoms of UTI and fever. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization was performed by using a computer generated randomization table” Comment: adequate randomisation method |
Allocation concealment (selection bias) | Low risk | Quote: “Allocation group was kept in sealed envelope. The operating surgeon was made aware of randomization and accordingly the patient was assigned to one of the two groups. In all cases, the envelope was opened at the end of the surgical procedure” Comment: adequate concealment method |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Blinding not possible due to intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: “a limitation of our study may exist in the fact that the observer of outcome was not blinded to the randomization” Comment: observer was not blinded to randomisation |
Blinding of microbiological outcome (detection bias) | Low risk | Quote: “A clear voided midstream urine specimen was obtained on the second postoperative day for culture and sensitivity.” Comment: urine samples likely were sent to a laboratory and so microbiologist is unlikely to know which patients belong to the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported, all participants who were randomised were included in analysis |
Selective reporting (reporting bias) | Unclear risk | Symptomatic UTI does not seem to be reported |
Other bias | Low risk | Appears to be free from other sources of bias |